drugset / Trial / NCT02319031
Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.
Timeline
- Start
- 2015-02
- Primary completion
- 2015-10
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Daclatasvir | Small molecule | 60 mg | Oral |
| Comparator | Ribavirin | Small molecule | 1000 mg | Oral |
| Comparator | Ribavirin | Small molecule | 1200 mg | Oral |
| Comparator | Sofosbuvir | Small molecule | 400 mg | Oral |