Last reviewed · How we verify
A Randomized, Multicenter, Open Label Study Evaluating the Efficacy and Safety of Tailored Regimens With Peginterferon Alfa-2a Plus Ribavirin According Viral Kinetics for Genotype 1 Chronic Hepatitis C Patients
The purposes of this study are: 1. To test if 36 weeks of standard dose of ribavirin with PEGASYS® is non-inferior to standard dose of 48 weeks of ribavirin with PEGASYS® in SVR for patients with RVR and HVL 2. To test if the 72 weeks of treatment with PEGASYS® plus standard dose ribavirin is superior to 48 weeks of the same treatment for patients with HCV RNA seropositivity at week 12
Details
| Lead sponsor | Kaohsiung Medical University Chung-Ho Memorial Hospital |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 542 |
| Start date | 2010-03 |
| Completion | 2016-12 |
Conditions
- Hepatitis C
Interventions
- A: Peg-interferon alpha-2a & Ribavirin
- B: Peg-interferon alpha-2a & Ribavirin
- C: Peg-interferon alpha-2a & Ribavirin
- D: Peg-interferon alpha-2a & Ribavirin
- E: Peg-interferon alpha-2a & Ribavirin
- F: Peg-interferon alpha-2a & Ribavirin
Primary outcomes
- Efficacy — 24-week off-treatment period
Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4 Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period
Countries
Taiwan