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

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.

Timeline

Start

2007-03

Primary completion

2010-12

Completion

2010-12

Outcome

Missed primary endpoint

paper As the upper limit of the 95% CI of the ORs were >1.88, 24 weeks were inferior to 48 weeks PMID 22045673 ↗

paper and 90 μg/week was inferior to 180 μg/week. PMID 22045673 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Peginterferon alfa-2a	Protein / enzyme biologic	90 ug	Subcutaneous
Subject	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous

Indications