- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00435825
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
June 19, 2013 updated by: Hoffmann-La Roche
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
551
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fitzroy, Australia, 3065
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Greenslopes, Australia, 4120
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Woolloongabba, Australia, 4102
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Campinas, Brazil, 13081-970
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Ribeirão Preto, Brazil, 14049-900
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Salvador, Brazil, 40150-130
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Santo Andre, Brazil, 09060-650
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Sao Paulo, Brazil, 05403-000
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Beijing, China, 100050
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Beijing, China, 100054
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Guangzhou, China, 510630
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Hunan, China, 410008
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Shanghai, China, 200025
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Shanghai, China, 201508
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Clichy, France, 92118
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Montpellier, France, 34295
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Nice, France, 06202
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Strasbourg, France, 67091
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Toulouse, France, 31078
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Villejuif, France, 94804
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Berlin, Germany, 13353
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Frankfurt Am Main, Germany, 60590
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Freiburg, Germany, 79106
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Hannover, Germany, 30625
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Köln, Germany, 50937
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong, 852
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 120-752
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Auckland, New Zealand, 100
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Hamilton, New Zealand
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Samara, Russian Federation, 443021
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Smolensk, Russian Federation, 214006
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St Petersburg, Russian Federation, 190103
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Stavropol, Russian Federation, 355017
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Singapore, Singapore, 169608
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Kaohsiung, Taiwan, 807
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Taipei, Taiwan, 100
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Taoyuan, Taiwan, 333
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Bangkok, Thailand, 10400
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Bangkok, Thailand, 10700
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Chiang Mai, Thailand, 50202
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Khon Kaen, Thailand, 40002
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Songkhla, Thailand, 90112
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California
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Los Angeles, California, United States, 90095
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Palo Alto, California, United States, 94304-1509
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San Diego, California, United States, 92105
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San Francisco, California, United States, 94115
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San Jose, California, United States, 95116
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Georgia
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Atlanta, Georgia, United States, 30306
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New York
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Flushing, New York, United States, 11355
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Oregon
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Portland, Oregon, United States, 97227
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19141
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Virginia
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Richmond, Virginia, United States, 23249
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: peginterferon alfa-2a 90 μg_24 Weeks
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
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90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.
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Experimental: peginterferon alfa-2a 180 μg_24 Weeks
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
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90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.
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Experimental: peginterferon alfa-2a 90 μg_48 Weeks
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
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90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.
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Experimental: peginterferon alfa-2a 180 μg_48 Weeks
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
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90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment
Time Frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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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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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 Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72
Time Frame: Week 72
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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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Week 72
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Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment
Time Frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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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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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment
Time Frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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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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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment
Time Frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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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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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Percentage of Participants With Normal Alanine Aminotransferase (ALT)
Time Frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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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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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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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
Time Frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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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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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment
Time Frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment)
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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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24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment)
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Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment
Time Frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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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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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment
Time Frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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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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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment
Time Frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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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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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Quantitative HBV-DNA 24 Weeks Following End of Treatment
Time Frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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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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24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
February 15, 2007
First Submitted That Met QC Criteria
February 15, 2007
First Posted (Estimate)
February 16, 2007
Study Record Updates
Last Update Posted (Estimate)
June 25, 2013
Last Update Submitted That Met QC Criteria
June 19, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Peginterferon alfa-2a
Other Study ID Numbers
- WV19432
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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