drugset / Trial / NCT00460850

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.

NCT00460850

Phase 4 Terminated 60 enrolled Hoffmann-La Roche
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Timeline

Start
2007-09
Primary completion
Completion
2008-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon Alfa-2a (40KD) Unknown 180 ug Subcutaneous