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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00927082
Registration number
NCT00927082
Ethics application status
Date submitted
16/06/2009
Date registered
24/06/2009
Date last updated
9/03/2016
Titles & IDs
Public title
A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B
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Scientific title
A Follow-up Study to Evaluate the Long-term Post Treatment Effects of Peginterferon Alfa-2a (PEG-IFN) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study WV19432(NEPTUNE).
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Secondary ID [1]
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MV22430
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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]
Experimental: PEG-IFN 90mcg 24 Wks - Participants received Pegasys (Pegylated interferon alfa-2a [PEG-IFN]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.
Experimental: PEG-IFN 180mcg 24 Wks - Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
Experimental: PEG-IFN 90mcg 48 Wks - Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
Experimental: PEG-IFN 180mcg 48 Wks - Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
Treatment: Drugs: peginterferon alfa-2a [Pegasys]
90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)
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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 Hepatitis B Envelope Antigen (HBeAg) Seroconversion.
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Assessment method [1]
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HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response.
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Timepoint [1]
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Annually, for up to 5 years
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Primary outcome [2]
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Percentage of Participants With HBsAg Loss
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Assessment method [2]
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HBsAg loss is defined as the absence of HBsAg (i.e. a negative result for HBsAg). Missing values were counted as non-response.
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Timepoint [2]
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Annually, for up to 5 years
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Secondary outcome [1]
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Percentage of Participants With HBeAg Loss.
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Assessment method [1]
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HBeAg loss is defined as the absence of HBeAg (i.e. a negative result for HBeAg). Missing values were counted as non-response.
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Timepoint [1]
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Annually, for up to 5 years
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Secondary outcome [2]
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.
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Assessment method [2]
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HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Missing values were counted as non-response.
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Timepoint [2]
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Annually, for up to 5 years
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Secondary outcome [3]
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Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).
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Assessment method [3]
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The presence of anti-HBe is defined as antibody produced against e antigen in HBeAg. Seroconversion from e antigen to e antibody (anti-HBe) is a predictor of long-term clearance of hepatitis B virus (HBV) in participants undergoing antiviral therapy and indicates lower levels of HBV, and therefore lower infectivity. Missing values were counted as non-response.
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Timepoint [3]
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Annually, for up to 5 years
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Secondary outcome [4]
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Percentage of Participants With Presence of Anti-HBs
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Assessment method [4]
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The presence of anti-HBs is defined as antibody produced against HBsAg.It is generally interpreted as indicating recovery and immunity from HBV infection. Missing values were counted as non-response.
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Timepoint [4]
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Annually, for up to 5 years
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Secondary outcome [5]
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Percentage of Participants With Normalised Alanine Transaminase (ALT)
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Assessment method [5]
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Alanine Transaminase is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT levels increase. Missing values were counted as non-response.
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Timepoint [5]
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Annually, for up to 5 years
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Secondary outcome [6]
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Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).
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Assessment method [6]
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The percentage of participants with HBV-DNA suppression < 20,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.
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Timepoint [6]
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Annually, for up to 5 years
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Secondary outcome [7]
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Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)
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Assessment method [7]
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The percentage of participants with HBV-DNA suppression < 2,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.
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Timepoint [7]
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Annually, for up to 5 years
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Secondary outcome [8]
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Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)
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Assessment method [8]
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The percentage of participants with HBV-DNA suppression < 80 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.
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Timepoint [8]
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Annually, for up to 5 years
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Secondary outcome [9]
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Quantitative HBsAg
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Assessment method [9]
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Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic Hepatitis B participants. Missing values were counted as non-response.
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Timepoint [9]
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Annually, for up to 5 years
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Secondary outcome [10]
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Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
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Assessment method [10]
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Participants who required additional treatments specifically to treat CHB, associated laboratory test abnormalities and associated symptoms in this long-term observation in the study were reported. Receipt of such treatment did not require participant withdrawal from further participation.
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Timepoint [10]
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Up to 5-year FU period
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Secondary outcome [11]
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Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
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Assessment method [11]
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Clinically significant events were defined as one or more of the following: Hepatocellular carcinoma, hepatic decompensation, CHB-related death, hepatic transplant, marked elevation of serum ALT of >10 x upper limit of normal (ULN).
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Timepoint [11]
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Up to 5-year FU period
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Secondary outcome [12]
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Number of Participants With Marked Laboratory Abnormalities
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Assessment method [12]
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Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Roche's following reference ranges for laboratory test parameters were used for the analysis: Hemoglobin (reference range: 110-200 grams/liter[g/L]), White blood cells (WBC) (3.0-18.0 ^10^9/L), Platelets (100-550 ^10^9/L), Neutrophils (1.50-9.25 ^10^9/L), Prothrombin time (PT) Normal ratio (n.d.-2.00), Alkaline phosphatase (0-220 units/liter [U/L]), Alanine aminotransferase (0-110 U/L), Aspartate transaminase (0-80 U/L), Total bilirubin (0-34 micromole/liter [umol/L]), Gamma-glutamyl transpeptidase (GGT) (0-190 U/L), Blood urea nitrogen (BUN) (0.0-14.3 millimole/liter [mmol/L]), Creatinine (0-154 umol/L), Total Protein (55-87 g/L), Albumin (30.0-n.d. g/L), Potassium (2.9-5.8 mmol/L), Sodium (130-150 mmol/L), Calcium (2.00-2.90 mmol/L), Uric acid (0-600 umol/L). It includes marked abnormalities observed during Study WV19432 and FU study MV22430
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Timepoint [12]
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Up to 5-year FU period
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Eligibility
Key inclusion criteria
- Informed consent for Study WV19432
- Patients who have completed treatment and follow-up on study WV19432
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- As for Study WV19432
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Study design
Purpose of the study
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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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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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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
1/04/2009
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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
1/11/2014
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Sample size
Target
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Accrual to date
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Final
383
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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- Fitzroy
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Recruitment postcode(s) [1]
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3065 - Fitzroy
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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BA
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Country [2]
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Brazil
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State/province [2]
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SP
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Country [3]
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China
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State/province [3]
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Beijing
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Country [4]
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China
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State/province [4]
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Changsha
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Country [5]
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China
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State/province [5]
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Guangzhou
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Country [6]
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China
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State/province [6]
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Shanghai
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Country [7]
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Hong Kong
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State/province [7]
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Hong Kong
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Country [8]
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Korea, Republic of
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State/province [8]
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Seoul
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Country [9]
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New Zealand
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State/province [9]
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Auckland
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Country [10]
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New Zealand
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State/province [10]
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Hamilton
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Country [11]
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Russian Federation
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State/province [11]
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Samara
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Country [12]
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Russian Federation
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State/province [12]
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St Petersburg
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Country [13]
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Russian Federation
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State/province [13]
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Stavropol
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Country [14]
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Singapore
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State/province [14]
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Singapore
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Country [15]
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Taiwan
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State/province [15]
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Kaohsiung
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Country [16]
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Taiwan
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State/province [16]
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Taipei
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Country [17]
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Taiwan
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State/province [17]
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Taoyuan
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Country [18]
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Thailand
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State/province [18]
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Bangkok
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Country [19]
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Thailand
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State/province [19]
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Chiang Mai
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Country [20]
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Thailand
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State/province [20]
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Khon Kaen
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Country [21]
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Thailand
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State/province [21]
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Songkhla
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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 study is a long-term post-treatment follow-up to study WV19432, which evaluated the
efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B
(CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to
enter this post-treatment follow-up study. The anticipated time on study was 5 years, and the
target sample size is 100-500 individuals.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00927082
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00927082
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