At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 68 enrolled

Drug / intervention

Simeprevir 150 mg +2 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/NCT02349048

NCT02349048Phase 2Completed

Compare CT.gov

A Phase 2, Randomized, Open-label Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of 6 or 8 Weeks of Treatment With Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

Janssen Research & Development, LLC·interventional·Posted Jan 28, 2015·Updated Mar 1, 2017

In Brief

A Phase 2 clinical trial evaluating Simeprevir 150 mg, Daclatasvir 60 mg, and 1 other intervention for Hepatitis C Virus. Completed, enrolled 68 participants across 8 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not having received treatment with any approved or investigational drug) participants with chronic hepatitis (inflammation of the liver) C virus (HCV) genotype 1 infection with early stages of liver fibrosis or with cirrhosis.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis C Virus

CountriesCanada, United States

Collaborators--

Timeline

Phase 2CompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartJan 2015

First PostedJan 2015

Primary CompletionFeb 2016

Study CompletionMay 2016

TodayJul 2026

First PostedJan 28, 2015

Enrollment StartJan 1, 2015

Primary CompletionFeb 1, 2016

Study CompletionMay 1, 2016

TodayJul 2, 2026

Enrollment to primary: 1.1 yearsPosted 11.4 years ago

Interventions

Simeprevir 150 mgdrug

Simeprevir 150 mg capsule orally once daily.

Daclatasvir 60 mgdrug

Daclatasvir 60 mg tablet orally once daily.

Sofosbuvir 400 mgdrug

Sofosbuvir 400 mg tablet orally once daily.