NCT00435825

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 551 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	peginterferon alfa-2a [Pegasys]	90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-02-16
• Last updated: 2013-06-25
• Results posted: 2013-06-25

Locations

55 sites across 13 countries: United States, Australia, Brazil, China, France, Germany, Hong Kong, New Zealand, Russia, Singapore, South Korea, Taiwan, Thailand