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An Open Label Phase IV Multicenter Study for Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Patients With HBeAg Positive Chronic Hepatitis B
This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 150 |
| Start date | 2005-10 |
| Completion | 2008-06 |
Conditions
- Hepatitis B, Chronic
Interventions
- peginterferon alfa-2a [Pegasys]
Primary outcomes
- Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72 — Week 72
Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders. - Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72 — Week 72
Participants with loss of hepatitis B virus e antigen (HBeAg) at the EOF period (24 weeks after the end of treatment) were classified as responders.
Countries
South Korea