drugset
drugset / Trial / NCT01973049

UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis

NCT01973049 ↗

Phase 3 Completed 202 enrolled Bristol-Myers Squibb
RandomizedParallel-groupTriple-blindTreatment

Summary

To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.

Timeline

Start
2013-12
Primary completion
2014-08
Completion
2014-11

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Asunaprevir Small molecule 200 mg Oral
Subject Beclabuvir Small molecule 75 mg Oral
Subject Daclatasvir Small molecule 30 mg Oral
Subject Ribavirin Small molecule 1000 mg Oral
Subject Ribavirin Small molecule 1200 mg Oral

Indications

chronic hepatitis C virus infection