drugset / Trial / NCT00299923
Study for Patients With Chronic HCV (GT 1 or 3) Who Relapsed to Previous (Peg)Interferon/ Ribavirin Combination Therapy
Phase 3
Unknown
300 enrolled
University of Hamburg-Eppendorf
Hoffmann-La Roche · collabUniversitätsklinikum Hamburg-Eppendorf · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is, to compare the relapse rate in chronic HCV patients with genotype 1 or 3 under the combination of standard dose Peg-Interferon alfa-2a (PEG-IFN alfa-2a), Ribavirin (RBV) and Amantadine (AMA) given for 72 weeks (group A), versus the same combination, given for 48 weeks (group B) in patients who relapsed to previous combination therapy to conventional or pegylated (PEG) Interferon alfa and Ribavirin. Relapse ist defined as percentage of patients with non-detectable HCV-RNA at end of therapy (week 48 GT1/ week 24 GT 3) who become HCV-RNA positive during a follow-up period of 24 weeks.
Timeline
- Start
- 2005-11
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amantadine | Unknown | — | — |
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | — | — |
| Subject | Ribavirin | Small molecule | — | — |