A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).

Completed · Phase 4

Conditions studied: Hepatitis B, Chronic

In brief

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.

Key facts

Study ID

NCT00435825

Run by

Hoffmann-La Roche

People needed

551

Starts

2007-03-01

Expected to finish

2010-12-01

Last updated by the study team

2013-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Palo Alto, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — San Jose, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Flushing, New York, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Richmond, Virginia, United States
• Study site — Fitzroy, Australia
• Study site — Greenslopes, Australia
• Study site — Woolloongabba, Australia
• Study site — Campinas, Brazil
• Study site — Ribeirão Preto, Brazil
• Study site — Salvador, Brazil
• Study site — Santo André, Brazil
• Study site — São Paulo, Brazil
• Study site — Beijing, China
• Study site — Beijing, China
• Study site — Guangzhou, China
• Study site — Hunan, China
• Study site — Shanghai, China
• Study site — Shanghai, China
• Study site — Clichy, France
• Study site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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