NCT01628692

Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus

A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy With Genotype 1 Chronic Hepatitis C

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.

Conditions

• Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	Daclatasvir	Tablets, oral, 30 mg, once daily
DRUG	Simeprevir	Capsule, oral, 150 mg, once daily
DRUG	Ribavirin	Tablets, oral, 500-600 mg, twice daily

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-08-01
• Completion: 2013-11-01
• First posted: 2012-06-27
• Last updated: 2017-02-23
• Results posted: 2015-11-30

Locations

26 sites across 6 countries: United States, Argentina, France, Germany, Hungary, Spain