drugset / Trial / NCT02032875

Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant

NCT02032875

Phase 3 Completed 116 enrolled Bristol-Myers Squibb
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This trial was open to participants who had received a liver transplant or had cirrhosis due to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were followed for 24 weeks post treatment. Under certain conditions, the treatment duration could have been extended for cirrhotic participants. The study tested the efficacy and safety of this combination for treatment of HCV in cirrhotic and post transplant patients.

Timeline

Start
2014-03
Primary completion
2014-11
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Daclatasvir Small molecule 60 mg Oral
Subject Ribavirin Small molecule Oral
Subject Sofosbuvir Small molecule 400 mg Oral