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An Open-label, Multicenter, National, Not-randomized Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (PEGASYS) in Patients With HBeAg-negative Chronic Hepatitis B
This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 60 |
| Start date | 2004-11 |
| Completion | 2007-02 |
Conditions
- Hepatitis B, Chronic
Interventions
- Peginterferon alfa-2a
Primary outcomes
- Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up — 72 Weeks
- Alanine Transaminase (ALT) Normalization at the End of Follow-Up — 72 Weeks
Countries
Bulgaria