drugset
drugset / Trial / NCT01425970

Chronically-infected HCV Genotype 2 and 3 Treatment-naive Subjects: Part A: Safety and Efficacy of INX-08189 With Peg IFN Alfa-2a and Ribavirin. Part B: INX-08189 in Interferon Free Treatment With Daclatasvir and/or Ribavirin

NCT01425970 ↗

Phase 2 Terminated 210 enrolled Bristol-Myers Squibb
RandomizedParallel-groupDouble-blindTreatment

Summary

Part A: The purpose of this study is to evaluate the safety and tolerability of INX-08189 and placebo with Peginterferon alfa-2a and Ribavirin during 12 weeks of treatment Part B: The purpose of this study is to evaluate the safety and tolerability of INX-08189 with Ribavirin or INX-08189 with Daclatasvir or INX-08189 with Daclatasvir and Ribavirin

Timeline

Start
2012-05
Primary completion
2013-08
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject BMS-986094 Small molecule 25 mg Oral
Subject BMS-986094 Small molecule 50 mg Oral
Subject BMS-986094 Small molecule 100 mg Oral
Subject BMS-986094 Small molecule 200 mg Oral
Subject Daclatasvir Small molecule 60 mg Oral
Background Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Background Ribavirin Small molecule 500 mg Oral
Background Ribavirin Small molecule 600 mg Oral

Indications

hepatitis C virus infection