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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01519960
Registration number
NCT01519960
Ethics application status
Date submitted
6/12/2011
Date registered
27/01/2012
Date last updated
18/11/2022
Titles & IDs
Public title
A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
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Scientific title
A Phase IIIb Parallel Group, Open Label Study of Pegylated Interferon Alfa-2a Monotherapy (PEG-IFN, Ro 25-8310) Compared to Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
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Secondary ID [1]
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2011-002732-70
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Secondary ID [2]
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YV25718
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - peginterferon alfa-2a [Pegasys]
Treatment: Drugs - peginterferon alfa-2a [Pegasys]
Experimental: A Pegasys -
No intervention: B Untreated Control -
Experimental: C Fibrosis non-randomized -
Experimental: Switch -
Treatment: Drugs: peginterferon alfa-2a [Pegasys]
Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48
Treatment: Drugs: peginterferon alfa-2a [Pegasys]
Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, after Week 48 for Group B patients who have not experienced HBeAg seroconversion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B
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Assessment method [1]
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HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.
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Timepoint [1]
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FU Week 24 (up to 72 weeks overall)
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Secondary outcome [1]
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Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B
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Assessment method [1]
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0
The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [1]
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FU Week 24 (up to 72 weeks overall)
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Secondary outcome [2]
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B
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Assessment method [2]
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HBsAg seroconversion was defined as loss of HBsAg and the presence of hepatitis B surface antibody (anti-HBs). The percentage of participants with HBsAg seroconversion at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [2]
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FU Week 24 (up to 72 weeks overall)
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Secondary outcome [3]
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Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B
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Assessment method [3]
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Normal ALT was defined as ALT less than or equal to (=) ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [3]
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FU Week 24 (up to 72 weeks overall)
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Secondary outcome [4]
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Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B
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Assessment method [4]
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HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [4]
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FU Week 24 (up to 72 weeks overall)
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Secondary outcome [5]
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Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B
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Assessment method [5]
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HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [5]
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0
FU Week 24 (up to 72 weeks overall)
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Secondary outcome [6]
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0
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B
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Assessment method [6]
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0
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [6]
0
0
FU Week 24 (up to 72 weeks overall)
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Secondary outcome [7]
0
0
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B
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Assessment method [7]
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0
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [7]
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0
FU Week 24 (up to 72 weeks overall)
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Secondary outcome [8]
0
0
Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B
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Assessment method [8]
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0
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [8]
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0
Week 48
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Secondary outcome [9]
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0
Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B
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Assessment method [9]
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0
The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [9]
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0
Week 48
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Secondary outcome [10]
0
0
Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B
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Assessment method [10]
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0
HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [10]
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0
Week 48
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Secondary outcome [11]
0
0
Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B
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Assessment method [11]
0
0
The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [11]
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0
Week 48
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Secondary outcome [12]
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0
Percentage of Participants With Normal ALT at EOT/POP in Groups A and B
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Assessment method [12]
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0
Normal ALT was defined as ALT = ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [12]
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0
Week 48
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Secondary outcome [13]
0
0
Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B
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Assessment method [13]
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HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [13]
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0
Week 48
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Secondary outcome [14]
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0
Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B
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Assessment method [14]
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HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [14]
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0
Week 48
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Secondary outcome [15]
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0
Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B
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Assessment method [15]
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0
HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA \<29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [15]
0
0
Week 48
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Secondary outcome [16]
0
0
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B
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Assessment method [16]
0
0
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [16]
0
0
Week 48
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Secondary outcome [17]
0
0
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B
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Assessment method [17]
0
0
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
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Timepoint [17]
0
0
Week 48
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Secondary outcome [18]
0
0
Quantitative Serum ALT Level in Groups A and B
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Assessment method [18]
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0
Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
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Timepoint [18]
0
0
Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
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Secondary outcome [19]
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0
Quantitative HBV DNA Level in Groups A and B
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Assessment method [19]
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0
Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
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Timepoint [19]
0
0
Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
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Secondary outcome [20]
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0
Change From Baseline in Quantitative HBV DNA Level in Groups A and B
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Assessment method [20]
0
0
The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
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Timepoint [20]
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0
Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
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Secondary outcome [21]
0
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Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C
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Assessment method [21]
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0
The percentage of participants with loss of HBeAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population: All participants who received at least one dose of study drug (if assigned) and had at least one post-baseline safety assessment.
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Timepoint [21]
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0
FU Week 24 (up to 72 weeks overall)
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Secondary outcome [22]
0
0
Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C
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Assessment method [22]
0
0
HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [22]
0
0
FU Week 24 (up to 72 weeks overall)
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Secondary outcome [23]
0
0
Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C
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Assessment method [23]
0
0
The percentage of participants with loss of HBsAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population
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Timepoint [23]
0
0
FU Week 24 (up to 72 weeks overall)
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Secondary outcome [24]
0
0
Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C
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Assessment method [24]
0
0
Normal ALT was defined as ALT = ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [24]
0
0
FU Week 24 (up to 72 weeks overall)
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Secondary outcome [25]
0
0
Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C
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Assessment method [25]
0
0
HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [25]
0
0
FU Week 24 (up to 72 weeks overall)
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Secondary outcome [26]
0
0
Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C
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Assessment method [26]
0
0
HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [26]
0
0
FU Week 24 (up to 72 weeks overall)
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Secondary outcome [27]
0
0
Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C
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Assessment method [27]
0
0
HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA \<29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [27]
0
0
FU Week 24 (up to 72 weeks overall)
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Secondary outcome [28]
0
0
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C
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Assessment method [28]
0
0
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [28]
0
0
FU Week 24 (up to 72 weeks overall)
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Secondary outcome [29]
0
0
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C
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Assessment method [29]
0
0
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [29]
0
0
FU Week 24 (up to 72 weeks overall)
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Secondary outcome [30]
0
0
Percentage of Participants With HBeAg Seroconversion at EOT in Group C
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Assessment method [30]
0
0
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [30]
0
0
Week 48
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Secondary outcome [31]
0
0
Percentage of Participants With Loss of HBeAg at EOT in Group C
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Assessment method [31]
0
0
The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [31]
0
0
Week 48
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Secondary outcome [32]
0
0
Percentage of Participants With HBsAg Seroconversion at EOT in Group C
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Assessment method [32]
0
0
HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [32]
0
0
Week 48
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Secondary outcome [33]
0
0
Percentage of Participants With Loss of HBsAg at EOT in Group C
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Assessment method [33]
0
0
The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [33]
0
0
Week 48
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Secondary outcome [34]
0
0
Percentage of Participants With Normal ALT at EOT in Group C
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Assessment method [34]
0
0
Normal ALT was defined as ALT = ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [34]
0
0
Week 48
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Secondary outcome [35]
0
0
Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C
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Assessment method [35]
0
0
HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [35]
0
0
Week 48
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Secondary outcome [36]
0
0
Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C
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Assessment method [36]
0
0
HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [36]
0
0
Week 48
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Secondary outcome [37]
0
0
Percentage of Participants With HBV DNA Undetectable at EOT in Group C
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Assessment method [37]
0
0
HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA \<29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
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Timepoint [37]
0
0
Week 48
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Secondary outcome [38]
0
0
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C
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Assessment method [38]
0
0
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Query!
Timepoint [38]
0
0
Week 48
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Secondary outcome [39]
0
0
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C
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Assessment method [39]
0
0
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Query!
Timepoint [39]
0
0
Week 48
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Secondary outcome [40]
0
0
Quantitative Serum ALT Level in Group C
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Assessment method [40]
0
0
Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [40]
0
0
Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
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Secondary outcome [41]
0
0
Quantitative HBV DNA Level in Group C
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Assessment method [41]
0
0
Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [41]
0
0
Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
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Secondary outcome [42]
0
0
Change From Baseline in Quantitative HBV DNA Level in Group C
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Assessment method [42]
0
0
The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [42]
0
0
Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
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Secondary outcome [43]
0
0
Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category
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Assessment method [43]
0
0
AUC was estimated using population pharmacokinetic (PK) modeling. The AUC at steady-state was averaged among participants who received PEG-IFN and reported by BSA category. Categories of BSA-based dosing used in the analysis were as follows: 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg. The estimated AUC was expressed in hours by nanograms per milliliter (h\*ng/mL). PK Substudy Population: All participants who consented to participate in the PK substudy. "Number of subjects analyzed" reflects the total combined number of participants who provided evaluable data across all BSA categories. The number of participants who provided evaluable data within each BSA category (n) is shown in the table.
Query!
Timepoint [43]
0
0
Pre-dose (0 hours) at Baseline and Weeks 4, 8, 12, 24; post-dose (24-48, 72-96, 168 hours) during Weeks 1, 24 (up to 24 weeks overall)
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Secondary outcome [44]
0
0
Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B
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Assessment method [44]
0
0
The percentage of participants with \>15% drop in height percentile for age from Baseline to each visit was reported. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [44]
0
0
Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)
Query!
Secondary outcome [45]
0
0
Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B
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Assessment method [45]
0
0
The percentage of participants with \>15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [45]
0
0
Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
Query!
Secondary outcome [46]
0
0
Quantitative HBeAg Level in Groups A and B
Query!
Assessment method [46]
0
0
Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 Paul Ehrlich Institute units per milliliter (PEIU/mL). ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [46]
0
0
Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [47]
0
0
Quantitative HBsAg Level in Groups A and B
Query!
Assessment method [47]
0
0
Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [47]
0
0
Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [48]
0
0
Quantitative HBeAg Level in Group C
Query!
Assessment method [48]
0
0
Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [48]
0
0
Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [49]
0
0
Quantitative HBsAg Level in Group C
Query!
Assessment method [49]
0
0
Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.
Query!
Timepoint [49]
0
0
Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [50]
0
0
Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C
Query!
Assessment method [50]
0
0
Liver elastography was performed to assess elasticity and extent of hepatic fibrosis. The change in LSM from Baseline to each visit was averaged among all participants in expressed in kilopascals (kPa). Positive changes in LSM values corresponded to an increase in stiffness and hepatic fibrosis. Liver Substudy Population: All participants who consented to participate in the liver elasticity substudy. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [50]
0
0
Week 48; FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [51]
0
0
Percentage of Participants With >15% Drop in Height Percentile for Age in Group C
Query!
Assessment method [51]
0
0
The percentage of participants with \>15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population.
Query!
Timepoint [51]
0
0
Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall)
Query!
Secondary outcome [52]
0
0
Change From Baseline in Height for Age Z-Score in Groups A and B
Query!
Assessment method [52]
0
0
The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [52]
0
0
Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)
Query!
Secondary outcome [53]
0
0
Change From Baseline in Weight for Age Z-Score in Groups A and B
Query!
Assessment method [53]
0
0
The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [53]
0
0
Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
Query!
Secondary outcome [54]
0
0
Change From Baseline in Height for Age Z-Score in Group C
Query!
Assessment method [54]
0
0
The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population.
Query!
Timepoint [54]
0
0
Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)
Query!
Secondary outcome [55]
0
0
Change From Baseline in Weight for Age Z-Score in Group C
Query!
Assessment method [55]
0
0
The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [55]
0
0
Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
Query!
Secondary outcome [56]
0
0
Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C
Query!
Assessment method [56]
0
0
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Query!
Timepoint [56]
0
0
FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [57]
0
0
Change From Baseline in Quantitative Serum ALT Level in Groups A and B
Query!
Assessment method [57]
0
0
The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [57]
0
0
Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
Query!
Secondary outcome [58]
0
0
Change From Baseline in Quantitative HBeAg Level in Groups A and B
Query!
Assessment method [58]
0
0
The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. ITT Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [58]
0
0
Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [59]
0
0
Change From Baseline in Quantitative HBsAg Level in Groups A and B
Query!
Assessment method [59]
0
0
The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [59]
0
0
Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [60]
0
0
Change From Baseline in Quantitative Serum ALT Level in Group C
Query!
Assessment method [60]
0
0
The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [60]
0
0
Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
Query!
Secondary outcome [61]
0
0
Change From Baseline in Quantitative HBeAg Level in Group C
Query!
Assessment method [61]
0
0
The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Query!
Timepoint [61]
0
0
Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [62]
0
0
Change From Baseline in Quantitative HBsAg Level in Group C
Query!
Assessment method [62]
0
0
The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.
Query!
Timepoint [62]
0
0
Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [63]
0
0
Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B
Query!
Assessment method [63]
0
0
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Query!
Timepoint [63]
0
0
Baseline, FU Years: 1, 2, 3, 4, 5
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Secondary outcome [64]
0
0
Percentage of Participants With Loss of HBeAg at 24 Weeks After the End of Switch Treatment Period: Switch Group
Query!
Assessment method [64]
0
0
The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Query!
Timepoint [64]
0
0
FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [65]
0
0
Percentage of Participants With HBsAg Seroconversion at 24 Weeks After the End of Switch Treatment Period: Switch Group
Query!
Assessment method [65]
0
0
HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.
Query!
Timepoint [65]
0
0
FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [66]
0
0
Percentage of Participants With Loss of HBsAg at 24 Weeks After the End of Switch Treatment Period: Switch Group
Query!
Assessment method [66]
0
0
HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.
Query!
Timepoint [66]
0
0
FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [67]
0
0
Percentage of Participants With Normal ALT at 24 Weeks After the End of Switch Treatment Period: Switch Group
Query!
Assessment method [67]
0
0
Normal ALT was defined as ALT = ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Query!
Timepoint [67]
0
0
FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [68]
0
0
Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After the End of Switch Treatment Period: Switch Group
Query!
Assessment method [68]
0
0
HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Query!
Timepoint [68]
0
0
FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [69]
0
0
Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group
Query!
Assessment method [69]
0
0
HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Query!
Timepoint [69]
0
0
FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [70]
0
0
Percentage of Participants With HBV DNA Undetectable at 24 Weeks After the End of Switch Treatment Period: Switch Group
Query!
Assessment method [70]
0
0
HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA \<29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Query!
Timepoint [70]
0
0
FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [71]
0
0
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group
Query!
Assessment method [71]
0
0
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Query!
Timepoint [71]
0
0
FU Week 24 (up to 72 weeks overall)
Query!
Secondary outcome [72]
0
0
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group
Query!
Assessment method [72]
0
0
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Query!
Timepoint [72]
0
0
FU Week 24 (up to 72 weeks overall)
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Eligibility
Key inclusion criteria
* Male or female patients, 3 years to <18 years of age at baseline
* Positive HBsAg for more than 6 months
* Positive HBeAg and detectable HBV DNA at screening
* A liver biopsy obtained within the past 2 years prior to baseline (and more than 6 months after the end of previous therapy for hepatitis B) to confirm the presence of advanced fibrosis or exclude cirrhosis
* Compensated liver disease (Child-Pugh Class A)
* Elevated serum alanine transferase (ALT)
* Normal thyroid gland function at screening
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Minimum age
3
Years
Query!
Query!
Maximum age
17
Years
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Query!
Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Subjects with cirrhosis
* Subjects must not have received investigational drugs or licensed treatments with anti-HBV activity within 6 months of baseline. Subjects who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded
* Known hypersensitivity to peginterferon
* Positive test results at screening for hepatitis A, hepatitis C, hepatitis D or HIV infection
* History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis B
* History or evidence of bleeding from esophageal varices
* Decompensated liver disease (e.g. ascites, Child-Pugh Class B or C)
* History of immunologically mediated disease
* Pregnant or lactating females
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Query!
Query!
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/07/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/10/2021
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Sample size
Target
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Accrual to date
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Final
165
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
0
0
Womens and Childrens Hospital; Department of Gastroenterology - North Adelaide
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Recruitment hospital [2]
0
0
Royal Children's Hospital; Department of Gastroenterology - Melbourne
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Recruitment postcode(s) [1]
0
0
5006 - North Adelaide
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Recruitment postcode(s) [2]
0
0
3053 - Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Maryland
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Massachusetts
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Missouri
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Texas
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Washington
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Country [7]
0
0
Belgium
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State/province [7]
0
0
Bruxelles
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Country [8]
0
0
Belgium
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State/province [8]
0
0
Gent
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Country [9]
0
0
Bulgaria
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State/province [9]
0
0
Sofia
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Country [10]
0
0
Bulgaria
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State/province [10]
0
0
Varna
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Country [11]
0
0
China
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State/province [11]
0
0
Beijing City
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Country [12]
0
0
China
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State/province [12]
0
0
Beijing
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Country [13]
0
0
China
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State/province [13]
0
0
Changchun
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Country [14]
0
0
China
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State/province [14]
0
0
Chongqing
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Country [15]
0
0
China
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State/province [15]
0
0
Guangzhou
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Country [16]
0
0
China
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State/province [16]
0
0
Kunming
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Country [17]
0
0
China
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State/province [17]
0
0
Urumqi (????)
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Country [18]
0
0
China
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State/province [18]
0
0
Wuhan
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Country [19]
0
0
China
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State/province [19]
0
0
Xi'an
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Country [20]
0
0
Germany
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State/province [20]
0
0
Wuppertal
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Country [21]
0
0
Israel
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State/province [21]
0
0
Haifa
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Country [22]
0
0
Israel
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State/province [22]
0
0
Jerusalem
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Country [23]
0
0
Israel
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State/province [23]
0
0
Nahariya
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Country [24]
0
0
Italy
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State/province [24]
0
0
Emilia-Romagna
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Country [25]
0
0
Poland
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State/province [25]
0
0
Bydgoszcz
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Country [26]
0
0
Poland
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State/province [26]
0
0
Krakow
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Country [27]
0
0
Poland
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State/province [27]
0
0
Lodz
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Country [28]
0
0
Russian Federation
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State/province [28]
0
0
Moscow
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Country [29]
0
0
Russian Federation
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State/province [29]
0
0
Saint Petersburg
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Country [30]
0
0
Russian Federation
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State/province [30]
0
0
Samara
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Country [31]
0
0
Ukraine
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State/province [31]
0
0
Kyiv
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Country [32]
0
0
United Kingdom
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State/province [32]
0
0
Birmingham
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Country [33]
0
0
United Kingdom
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State/province [33]
0
0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to \<18 years at baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment with Pegasys. Children in the untreated control Group B who have not experienced seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of Pegasys treatment. This offer will be available for 1 year following 48 weeks from randomization. Anticipated time on study treatment is 48 weeks. All subjects will be followed up for 5 years after the end of treatment (A,C,Switch)/principal observation (B) period.
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Trial website
https://clinicaltrials.gov/study/NCT01519960
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Trial related presentations / publications
Wirth S, Zhang H, Hardikar W, Schwarz KB, Sokal E, Yang W, Fan H, Morozov V, Mao Q, Deng H, Huang Y, Yang L, Frey N, Nasmyth-Miller C, Pavlovic V, Wat C. Efficacy and Safety of Peginterferon Alfa-2a (40KD) in Children With Chronic Hepatitis B: The PEG-B-ACTIVE Study. Hepatology. 2018 Nov;68(5):1681-1694. doi: 10.1002/hep.30050. Epub 2018 Oct 8.
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Public notes
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Contacts
Principal investigator
Name
0
0
Clinical Trials
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Address
0
0
Hoffmann-La Roche
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Query!
Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/60/NCT01519960/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/60/NCT01519960/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01519960
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