drugset / Trial / NCT00122629
Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous Hepatitis C Virus (HCV) Non Responders
Phase 3
Terminated
405 enrolled
French National Agency for Research on AIDS and Viral Hepatitis
Schering-Plough · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Triple antiviral therapy with peg-interferon-alfa/ribavirin+amantadine was suggested to increase sustained virological response (SVR) rates in HCV non-responders to a standard interferon/ribavirin combination. Patients with hepatitis C virus infection were eligible if they had failed to respond to a single previous 24 week cycle of interferon/ribavirin combination therapy. Non-response was defined as persistent HCV RNA in the serum during the last month of treatment. This study tested the efficacy and safety of pegylated interferon alfa-2b with ribavirin and amantadine or a placebo for 48 weeks.
Timeline
- Start
- 2000-10
- Primary completion
- —
- Completion
- 2003-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amantadine | Unknown | 200 mg | — |
| Background | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | — |
| Background | Ribavirin | Small molecule | 800 mg | — |
| Background | Ribavirin | Small molecule | 1200 mg | — |