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

NCT02319031

Phase 3 Completed 53 enrolled Bristol-Myers Squibb
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

EvaluationDrugModalityDoseRoute
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