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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00435825
Registration number
NCT00435825
Ethics application status
Date submitted
15/02/2007
Date registered
16/02/2007
Date last updated
25/06/2013
Titles & IDs
Public title
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
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Scientific title
A Randomized, Double-blind Study of the Effect of Treatment Duration and Dose of PEGASYS on HBeAg Seroconversion and Safety in Patients With HBeAg Positive Chronic Hepatitis B.
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Secondary ID [1]
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WV19432
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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: peginterferon alfa-2a 90 µg_24 Weeks - Participants received 90 micrograms (µg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
Experimental: peginterferon alfa-2a 180 µg_24 Weeks - Participants received 180 µg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
Experimental: peginterferon alfa-2a 90 µg_48 Weeks - Participants received 90 µg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
Experimental: peginterferon alfa-2a 180 µg_48 Weeks - Participants received 180 µg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
Treatment: Drugs: peginterferon alfa-2a [Pegasys]
90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.
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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 Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment
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Assessment method [1]
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Blood was collected for HBeAg. 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) determined at 24 weeks after the end of treatment.
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Timepoint [1]
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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Secondary outcome [1]
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Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72
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Assessment method [1]
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Blood was collected for HBeAg. 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-HBs) determined at Week 72.
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Timepoint [1]
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Week 72
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Secondary outcome [2]
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Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment
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Assessment method [2]
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Blood was collected HBeAg 24 Weeks following the end of treatment. Loss of HBeAg is defined as the absence of HBeAg.
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Timepoint [2]
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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Secondary outcome [3]
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment
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Assessment method [3]
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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) determined at 24 weeks after the end of treatment.
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Timepoint [3]
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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Secondary outcome [4]
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Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment
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Assessment method [4]
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Blood was collected for HBsAg 24 weeks following the end of treatment. Loss of HBsAg is defined as the absence of HBsAg.
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Timepoint [4]
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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Secondary outcome [5]
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Percentage of Participants With Normal Alanine Aminotransferase (ALT)
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Assessment method [5]
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Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay.
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Timepoint [5]
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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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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 IU/mL 24 Weeks Following End of Treatment
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Assessment method [6]
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Blood was collected for HBV-DNA 24 weeks following the end of treatment and was analyzed at the central laboratory using the Roche approved polymerase chain reaction (PCR) methodology. Percentage of participants with a HBV-DNA suppression of \< 20,000 IU/mL (Less than 100,000 copies/mL) is reported.
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Timepoint [6]
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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Secondary outcome [7]
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Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment
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Assessment method [7]
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Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. Percentage of participants with A HBV-DNA Suppression of \< 2,000 IU/mL (Less than 10,000 copies/mL) is reported.
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Timepoint [7]
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24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment)
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Secondary outcome [8]
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Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment
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Assessment method [8]
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Combined endpoint was defined as HBeAg seroconversion, a normal serum ALT and HBV-DNA suppression below 20,000 IU/mL.
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Timepoint [8]
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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Secondary outcome [9]
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Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment
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Assessment method [9]
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Dual endpoint was defined as the achievement of both HBeAg seroconversion and a HBV-DNA \<2,000 IU/ml (Less than 10,000 copies/mL).
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Timepoint [9]
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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Secondary outcome [10]
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Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment
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Assessment method [10]
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Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay: 0- 55 units/liter (U/L).
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Timepoint [10]
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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Secondary outcome [11]
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Quantitative HBV-DNA 24 Weeks Following End of Treatment
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Assessment method [11]
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Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment.
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Timepoint [11]
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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* positive Hepatitis B surface antigen (HBsAg) for >6 months, positive HBeAg, HBV DNA >500,000 copies/mL, and anti-HBs negative;
* liver disease consistent with Chronic Hepatitis B.
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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
* antiviral therapy for CHB within previous 6 months;
* co-infection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus (HDV) or Human immuno deficiency virus (HIV);
* evidence of decompensated liver disease;
* medical condition associated with chronic liver disease.
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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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
1/03/2007
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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
1/12/2010
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Sample size
Target
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Accrual to date
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Final
551
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Fitzroy
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Recruitment hospital [2]
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- Greenslopes
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Recruitment hospital [3]
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- Woolloongabba
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Recruitment postcode(s) [1]
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3065 - Fitzroy
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Recruitment postcode(s) [2]
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4120 - Greenslopes
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment outside Australia
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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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Georgia
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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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Oregon
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Pennsylvania
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United States of America
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Virginia
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Brazil
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Campinas
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Brazil
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Ribeirão Preto
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Brazil
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Salvador
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Brazil
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Santo Andre
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Brazil
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Sao Paulo
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China
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Beijing
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China
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Guangzhou
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China
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Hunan
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China
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France
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Clichy
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France
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Montpellier
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France
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Nice
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France
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France
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Berlin
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Germany
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Frankfurt Am Main
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Germany
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Freiburg
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Germany
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Hannover
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Germany
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Seoul
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Auckland
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New Zealand
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Hamilton
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Russian Federation
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Samara
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Russian Federation
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Smolensk
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Russian Federation
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Russian Federation
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Stavropol
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Singapore
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Kaohsiung
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Taoyuan
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
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Thailand
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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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Ethics approval
Ethics application status
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Summary
Brief summary
This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
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Trial website
https://clinicaltrials.gov/study/NCT00435825
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Trial related presentations / publications
Liaw YF, Jia JD, Chan HL, Han KH, Tanwandee T, Chuang WL, Tan DM, Chen XY, Gane E, Piratvisuth T, Chen L, Xie Q, Sung JJ, Wat C, Bernaards C, Cui Y, Marcellin P. Shorter durations and lower doses of peginterferon alfa-2a are associated with inferior hepatitis B e antigen seroconversion rates in hepatitis B virus genotypes B or C. Hepatology. 2011 Nov;54(5):1591-9. doi: 10.1002/hep.24555.
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Public notes
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Contacts
Principal investigator
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Address
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Hoffmann-La Roche
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00435825
Download to PDF