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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/NCT01277601
Registration number
NCT01277601
Ethics application status
Date submitted
13/01/2011
Date registered
17/01/2011
Date last updated
26/08/2016
Titles & IDs
Public title
Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon a-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B
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Scientific title
A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon a-2a (Pegasys®) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon a-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)
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Secondary ID [1]
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0
2010-024586-45
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Secondary ID [2]
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GS-US-174-0149
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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:
Chronic Hepatitis B
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0
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Condition category
Condition code
Infection
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0
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Other infectious diseases
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Oral and Gastrointestinal
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0
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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 - TDF
Treatment: Drugs - Peg-IFN
Experimental: TDF+Peg-IFN 48 Weeks - TDF plus Peg-IFN for 48 weeks
Experimental: TDF 48 Weeks + Peg-IFN 16 Weeks - TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
Active Comparator: TDF 120 Weeks - TDF monotherapy for 120 weeks
Active Comparator: Peg-IFN 48 Weeks - Peg-IFN monotherapy for 48 weeks
Treatment: Drugs: TDF
TDF 300 mg tablets administered orally once daily
Treatment: Drugs: Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
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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 HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone
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Assessment method [1]
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Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.
The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis.
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Timepoint [1]
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Baseline; Week 72
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Secondary outcome [1]
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Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone
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Assessment method [1]
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Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.
The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis.
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Timepoint [1]
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Baseline; Week 72
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Secondary outcome [2]
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Percentage of Participants With HBsAg Loss at Weeks 96 and 120
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Assessment method [2]
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Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.
The analysis visit window for Week 96 comprised study Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised study Week 114 through Week 126, so results up to Week 126 are included in this analysis.
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Timepoint [2]
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Baseline; Weeks 96 and 120
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Secondary outcome [3]
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Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120
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Assessment method [3]
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HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Proportions are based on a Kaplan-Meier estimate.
The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. The analysis visit window for Week 96 comprised Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised Week 114 through Week 120.
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Timepoint [3]
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Baseline; Weeks 72, 96, and 120
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Secondary outcome [4]
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Percentage of Participants With HBeAg Loss and Seroconversion at Week 72
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Assessment method [4]
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Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.
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Timepoint [4]
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Baseline; Week 72
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Secondary outcome [5]
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Percentage of Participants With HBeAg Loss and Seroconversion at Week 96
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Assessment method [5]
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Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.
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Timepoint [5]
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Baseline; Week 96
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Secondary outcome [6]
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Percentage of Participants With HBeAg Loss and Seroconversion at Week 120
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Assessment method [6]
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Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.
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Timepoint [6]
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Baseline; Week 120
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Secondary outcome [7]
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Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72
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Assessment method [7]
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For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.
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Timepoint [7]
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Week 72
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Secondary outcome [8]
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Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96
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Assessment method [8]
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For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.
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Timepoint [8]
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Week 96
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Secondary outcome [9]
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Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120
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Assessment method [9]
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0
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.
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Timepoint [9]
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Week 120
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Secondary outcome [10]
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Percentage of Participants With Normal ALT at Week 72
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Assessment method [10]
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Normal ALT was = 30 U/L for males and = 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and = 41 U/L for males and = 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.
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Timepoint [10]
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Week 72
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Secondary outcome [11]
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Percentage of Participants With Normal ALT at Week 96
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Assessment method [11]
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Normal ALT was = 30 U/L for males and = 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and = 41 U/L for males and = 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.
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Timepoint [11]
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Week 96
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Secondary outcome [12]
0
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Percentage of Participants With Normal ALT at Week 120
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Assessment method [12]
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Normal ALT was = 30 U/L for males and = 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and = 41 U/L for males and = 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.
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Timepoint [12]
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0
Week 120
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Secondary outcome [13]
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Percentage of Participants Who Required Retreatment
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Assessment method [13]
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Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.
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Timepoint [13]
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Up to 120 weeks
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Eligibility
Key inclusion criteria
- Adults (age 18-75) with chronic HBV (positive for serum hepatitis B surface antigen
(HBsAg) or HBV DNA for at least 6 months) prior to baseline
- Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside
therapy with the last dose = 24 weeks prior to screening are also eligible.
- Positive or negative for hepatitis B e antigen (HBeAg)
- HBV DNA = 20,000 IU/ml (HBeAg-positive participants) and = 2,000 IU/ml (HBeAg-negative
participants)
- Alanine aminotransferase (ALT) > 54 U/L and = 400 U/L for men and > 36 U/L and = 300
U/L for women
- Creatinine clearance = 70 mL/min
- Negative serum pregnancy test for females of childbearing potential
- Sexually active females of childbearing potential must agree to use a
protocol-recommended method of contraception throughout the study and for 30 days
following the last dose of study medication
- Lactating females must agree to discontinue nursing before initiation of study
investigational medicinal product
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Minimum age
18
Years
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Maximum age
75
Years
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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
- Known bridging fibrosis or cirrhosis and/or decompensated liver disease
- Evidence of hepatocellular carcinoma
- Significant kidney, heart, lung, neurological, autoimmune disease, or bone disease
(eg, osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis,
multiple bone fractures)
- Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, hemoglobin < 10 g/dL
(female) or < 11 g/dL (male)
- History of severe depression or severe psychiatric disease
- Thyroid dysfunction
- Coinfection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
- Pregnant
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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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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
1/04/2011
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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
1/07/2015
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Sample size
Target
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Accrual to date
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Final
751
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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0
Concord Repatriation General Hospital - Concord
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Recruitment hospital [3]
0
0
Saint George's Hospital - Kogarah
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Recruitment hospital [4]
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Liverpool Hospital,Gastroenterology Department - Liverpool
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Recruitment hospital [5]
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0
Westmead Hospital - Westmead
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Recruitment hospital [6]
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Royal Brisbane & Women's Hospital - Herston
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Recruitment hospital [7]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [8]
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Royal Adelaide Hospital - Adelaide SA
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Recruitment hospital [9]
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Flinders Medical Center - Adelaide
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Recruitment hospital [10]
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Monash Medical Centre - Clayton
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Recruitment hospital [11]
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Saint Vincents Hospital - Fitzroy
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Recruitment hospital [12]
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Western Hospital - Footscray
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Recruitment hospital [13]
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0
Austin Health - Heidelberg
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Recruitment hospital [14]
0
0
Alfred Hospital - Melbourne
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Recruitment hospital [15]
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0
Box Hill Hospital - Melbourne
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Recruitment hospital [16]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [17]
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Fremantle Hospital - Fremantle
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Recruitment hospital [18]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [19]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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- Camperdown
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Recruitment postcode(s) [2]
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- Concord
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Recruitment postcode(s) [3]
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- Kogarah
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Recruitment postcode(s) [4]
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- Liverpool
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Recruitment postcode(s) [5]
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- Westmead
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Recruitment postcode(s) [6]
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- Herston
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Recruitment postcode(s) [7]
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- Woolloongabba
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Recruitment postcode(s) [8]
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- Adelaide SA
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Recruitment postcode(s) [9]
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- Adelaide
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Recruitment postcode(s) [10]
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- Clayton
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Recruitment postcode(s) [11]
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- Fitzroy
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Recruitment postcode(s) [12]
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- Footscray
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Recruitment postcode(s) [13]
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- Heidelberg
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Recruitment postcode(s) [14]
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- Melbourne
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Recruitment postcode(s) [15]
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- Parkville
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Recruitment postcode(s) [16]
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- Fremantle
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Recruitment postcode(s) [17]
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- Nedlands
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Recruitment postcode(s) [18]
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- Perth
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Recruitment outside Australia
Country [1]
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United States of America
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California
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United States of America
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Florida
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United States of America
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Illinois
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0
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Pennsylvania
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United States of America
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Texas
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Utah
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United States of America
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Virginia
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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France
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Cedex
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France
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Paris
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France
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Rennes Cedex 9
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France
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Rouen
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France
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Strasbourg
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France
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Toulouse
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France
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Villejuif Cedex
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Germany
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Rheinland-pfalz
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Germany
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Berlin
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Germany
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Essen
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0
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Germany
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Frankfurt
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0
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Germany
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Hamburg
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0
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Germany
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Hannover
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0
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Germany
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Köln
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Germany
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Leipzig
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Greece
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Attica
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Greece
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Patra
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0
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Greece
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Thessaloniki
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0
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Hong Kong
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Hong Kong
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Hong Kong
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Kowloon
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Hong Kong
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Shatin
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Hong Kong
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Tai Po
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India
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Andhra Pradesh
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India
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Assam
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0
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India
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Gujarat
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India
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Karnataka
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India
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Maharashtra
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India
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0
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New Delhi
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0
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India
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Tamil Nadu
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0
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India
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0
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West Bengal
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0
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Italy
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Cagliari
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Italy
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Milano
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Italy
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Napoli
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0
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Italy
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Parma
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0
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Italy
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0
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Roma
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0
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Italy
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Rome
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0
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Italy
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Torino
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0
0
Korea, Republic of
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Chungcheon
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Korea, Republic of
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Gangwon-do
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Korea, Republic of
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Gyeonggi-d
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0
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Korea, Republic of
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Gyeongsang
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0
0
Korea, Republic of
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State/province [58]
0
0
Busan
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0
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Korea, Republic of
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State/province [59]
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0
Goyang, Gyeonggi-Do
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0
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Korea, Republic of
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0
Kwangjin-gu, Seoul
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Korea, Republic of
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Seoul
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0
0
Netherlands
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Amsterdam
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Netherlands
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Rotterdam
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Country [64]
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Poland
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Lodzkie
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Poland
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Lubelskie
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Poland
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Slaskie
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Warszawa
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Sibiu
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Romania
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Timisoara
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Spain
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Vigo, Pontevedra
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Taiwan
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Banciao Dist
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Taiwan
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Taoyuan
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Taiwan
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Changhua
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Taiwan
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Chia-Yi
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Taiwan
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Hualien
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Taiwan
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Kaohsiung
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Taiwan
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Kaosiung
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Taiwan
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Keelung Town/KEELUNG CITY
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Taiwan
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State/province [93]
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Turkey
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Ankara
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Turkey
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Gaziantep
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Turkey
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Istanbul
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Turkey
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State/province [99]
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Mersin
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United Kingdom
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State/province [100]
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Birmingham, WSTMID
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Country [101]
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United Kingdom
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State/province [101]
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Hampstead,London
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United Kingdom
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State/province [102]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Ethics approval
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Summary
Brief summary
The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil
fumarate (TDF) plus peginterferon a-2a (Peg-IFN) combination therapy for 48 weeks versus
standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults
with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen
(HBsAg).
The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks
+ Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment,
participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and
those meeting TDF retreatment and flare management criteria will be eligible to receive TDF
monotherapy during a retreatment phase, up to Week 120.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01277601
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Public notes
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Contacts
Principal investigator
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Belinda Jump
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Address
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Gilead Sciences
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01277601
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