A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
This open-label, multi-center study will evaluate the effect on the quantitative HBsAg
reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic
hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of
treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of
treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS
monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting
from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.
Phase:
Phase 4
Details
Lead Sponsor:
Hoffmann-La Roche
Collaborator:
Major Science and Technology Special Project of China Eleventh Five-year