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A Phase III, Multicentre, Double Blinded Study In Patients With Chronic Hepatitis C Who Are Non-Responders To Prior Peginterferon Alpha + Ribavirin Therapy Comparing Treatment With Thymosin Alpha 1 + Peginterferon Alpha-2a Plus Ribavirin With Peginterferon Alpha-2a + Ribavirin + Placebo
The purpose of the study was to determine safety and efficacy of 48 weeks treatment with Thymosin alpha 1 (Talpha1) in combination with pegylated interferon (PEGIFN) alpha2a and ribavirin (RBV) in adult patients with chronic hepatitis C (CHC) already treated with, and not responding to previous courses of PEGIFN alpha plus RBV combination therapy, in comparison with a concurrent group treated with PEG IFN alpha2a in combination with RBV and placebo.
Details
| Lead sponsor | sigma-tau i.f.r. S.p.A. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 552 |
| Start date | 2004-12 |
| Completion | 2009-07 |
Conditions
- Chronic Hepatitis C
Interventions
- Thymosin alpha 1
- Ribavirin
- PEGinterferon alfa2a
- Placebo
Primary outcomes
- Sustained Virological Response (SVR) — Week 72
The proportion of patients who were HCV RNA negative at the end of observation period.
Countries
France, Germany, Greece, Italy, Spain