NCT00436163

A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B

Baltic Post-marketing Program of PEGASYS (Peg Interferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly. Following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is less than 100 participants.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Peginterferon alfa-2a	180 mcg subcutaneously once per week for 48 weeks.

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2007-02-16
• Last updated: 2016-10-24
• Results posted: 2016-10-24

Locations

9 sites across 3 countries: Estonia, Latvia, Lithuania