CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Simeprevir +2 moredrug
Likely dose
Simeprevir 150 milligramfrom 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/NCT02262728
NCT02262728Phase 2Completed
CompareCT.gov

A Phase 2 Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of 12 Weeks of Treatment With Simeprevir, Daclatasvir and Sofosbuvir, Followed by a 5-Year Post-treatment Long-term Follow-up, in Treatment-naïve and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease

Janssen Research & Development, LLC·interventional·Posted Oct 13, 2014·Updated Feb 4, 2025

In Brief

A Phase 2 clinical trial evaluating Simeprevir, Daclatasvir, and 1 other intervention for Hepatitis C, Chronic. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the efficacy of a 12-week regimen containing simeprevir, daclatasvir and sofosbuvir in participants with decompensated liver disease (the liver function is insufficient) due to genotype 1 or 4 Hepatitis (inflammation of the liver) C virus (HCV) infection by assessing sustained virologic response 12-weeks after the end of study drug treatment (SVR12).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 13, 2014
Enrollment StartSep 30, 2014
Primary CompletionAug 13, 2015
Study CompletionApr 25, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.7 years ago

Interventions

Simeprevirdrug

Simeprevir 150 milligram (mg) capsule orally once daily for 12 weeks

Daclatasvirdrug

Daclatasvir 60 mg tablet orally once daily for 12 weeks

Sofosbuvirdrug

Sofosbuvir 400 mg tablet orally once daily for 12 weeks