NCT02268864

A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants

A Phase 2, Open-label Study to Investigate the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of a 12- or 24-week treatment regimen of simeprevir in combination with daclatasvir, as measured by sustain virologic response 12 (SVR12), in treatment-naive, chronic hepatitis C virus (HCV) genotype 1b-infected participants who have advanced fibrosis or compensated cirrhosis (METAVIR F3/F4).

Detailed description

This is an open-label (all people know which treatment the participants receive) study to investigate the efficacy, safety and tolerability of simeprevir and daclatasvir in chronic Hepatitis (inflammation of the liver) C virus (HCV) genotype 1b infected participants who are treatment-naive. The total study duration for each participant will be approximately 40 weeks or approximately 52 weeks. The study will consist of 4 parts: Screening Phase (approximately 4 weeks) and open-label treatment Phase (12 weeks), optional open label treatment phase extension (12 Weeks) and follow-up Phase (up to Week 40 or Week 52). Participants will receive simeprevir (150 milligram \[mg\] capsule) and daclatasvir (60 mg tablet) orally once daily for 12 or 24 weeks. Efficacy will be primarily evaluated by percentage of participants with SVR12. Participants' safety will be monitored throughout the study.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Simeprevir	Simeprevir 150 mg oral capsule will be administered once daily for 12 or 24 weeks.
DRUG	Daclatasvir	Daclatasvir 60 mg oral tablet will be administered once daily for 12 or 24 weeks.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-01-01
• Completion: 2016-04-01
• First posted: 2014-10-20
• Last updated: 2017-03-16
• Results posted: 2017-01-20

Locations

23 sites across 6 countries: Belgium, France, Germany, Hungary, Spain, United Kingdom