drugset / Trial / NCT01358864
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)
RandomizedParallel-groupDouble-blindTreatment
Summary
The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.
Timeline
- Start
- 2011-06
- Primary completion
- 2013-02
- Completion
- 2014-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Faldaprevir | Small molecule | 240 mg | — |
| Background | Pegylated Interferon-alpha | Protein / enzyme biologic | — | — |
| Background | Ribavirin | Small molecule | — | — |