CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 40 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/NCT02250807
NCT02250807Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

Janssen R&D Ireland·interventional·Posted Sep 26, 2014·Updated Nov 17, 2016

In Brief

A Phase 3 clinical trial evaluating Simeprevir and Sofosbuvir for Chronic Hepatitis C and Genotype 4 Chronic Hepatitis C. Completed, enrolled 40 participants across 6 sites.

Detailed Summary

The purpose of this study is to show superiority of simeprevir (SMV) in combination with sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite of the observed historical sustained virological response at Week 12 (SVR12) rates of SMV in combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C, Genotype 4 Chronic Hepatitis C
CountriesSpain
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 26, 2014
Enrollment StartJan 1, 2015
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.8 years ago

Interventions

Simeprevirdrug

Subjects will receive oral capsule of Simeprevir 150 mg, once a day from Day 1 up to Week 12.

Sofosbuvirdrug

Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12.