A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
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.
1 other identifier
interventional
551
13 countries
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2007
Longer than P75 for phase_4
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2007
CompletedFirst Posted
Study publicly available on registry
February 16, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
June 25, 2013
CompletedJune 25, 2013
June 1, 2013
3.8 years
February 15, 2007
March 20, 2013
June 19, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment
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.
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Secondary Outcomes (11)
Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72
Week 72
Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Percentage of Participants With Normal Alanine Aminotransferase (ALT)
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
- +6 more secondary outcomes
Study Arms (4)
peginterferon alfa-2a 90 μg_24 Weeks
EXPERIMENTALParticipants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
peginterferon alfa-2a 180 μg_24 Weeks
EXPERIMENTALParticipants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
peginterferon alfa-2a 90 μg_48 Weeks
EXPERIMENTALParticipants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
peginterferon alfa-2a 180 μg_48 Weeks
EXPERIMENTALParticipants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
Interventions
90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
Palo Alto, California, 94304-1509, United States
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San Diego, California, 92105, United States
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San Francisco, California, 94115, United States
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San Jose, California, 95116, United States
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Atlanta, Georgia, 30306, United States
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Flushing, New York, 11355, United States
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Portland, Oregon, 97227, United States
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Philadelphia, Pennsylvania, 19141, United States
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Richmond, Virginia, 23249, United States
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Fitzroy, 3065, Australia
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Greenslopes, 4120, Australia
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Woolloongabba, 4102, Australia
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Campinas, 13081-970, Brazil
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RibeirĂ£o Preto, 14049-900, Brazil
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Salvador, 40150-130, Brazil
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Santo André, 09060-650, Brazil
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SĂ£o Paulo, 05403-000, Brazil
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Beijing, 100050, China
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Beijing, 100054, China
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Guangzhou, 510630, China
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Hunan, 410008, China
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Shanghai, 200025, China
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Shanghai, 201508, China
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Clichy, 92118, France
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Montpellier, 34295, France
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Nice, 06202, France
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Strasbourg, 67091, France
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Toulouse, 31078, France
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Villejuif, 94804, France
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Berlin, 13353, Germany
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Cologne, 50937, Germany
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Frankfurt am Main, 60590, Germany
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Freiburg im Breisgau, 79106, Germany
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Hanover, 30625, Germany
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Hong Kong, 852, Hong Kong
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Hong Kong, Hong Kong
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Auckland, 100, New Zealand
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Hamilton, New Zealand
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Saint Petersburg, 190103, Russia
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Samara, 443021, Russia
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Smolensk, 214006, Russia
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Stavropol, 355017, Russia
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Singapore, 169608, Singapore
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Seoul, 110-744, South Korea
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Seoul, 120-752, South Korea
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Seoul, 138-736, South Korea
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Kaohsiung City, 807, Taiwan
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Taipei, 100, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50202, Thailand
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Khon Kaen, 40002, Thailand
Unknown Facility
Songkhla, 90112, Thailand
Related Publications (1)
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.
PMID: 22045673DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2007
First Posted
February 16, 2007
Study Start
March 1, 2007
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
June 25, 2013
Results First Posted
June 25, 2013
Record last verified: 2013-06