CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 106 enrolled
Drug / intervention
Simeprevir +1 moredrug
Likely dose
Simeprevir 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02268864
NCT02268864Phase 2Completed
CompareCT.gov

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

Janssen-Cilag International NV·interventional·Posted Oct 20, 2014·Updated Mar 16, 2017

In Brief

A Phase 2 clinical trial evaluating Simeprevir and Daclatasvir for Hepatitis C, Chronic. Completed, enrolled 106 participants across 23 sites in 6 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesBelgium, France, Germany, Hungary, Spain, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 20, 2014
Enrollment StartJan 1, 2015
Primary CompletionJan 1, 2016
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 11.7 years ago

Interventions

Simeprevirdrug

Simeprevir 150 mg oral capsule will be administered once daily for 12 or 24 weeks.

Daclatasvirdrug

Daclatasvir 60 mg oral tablet will be administered once daily for 12 or 24 weeks.