CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 310 enrolled
Drug / intervention
Simeprevir +3 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/NCT02114177
NCT02114177Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of a 12- or 8-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve and -Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection Without Cirrhosis

Janssen Infectious Diseases BVBA·interventional·Posted Apr 15, 2014·Updated Apr 12, 2016

In Brief

A Phase 3 clinical trial evaluating Simeprevir and Sofosbuvir for Hepatitis C Virus Infection. Completed, enrolled 310 participants across 40 sites in 2 countries.

Detailed Summary

The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or treatment-experienced.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 15, 2014
Enrollment StartApr 1, 2014
Primary CompletionJan 1, 2015
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.2 years ago

Interventions

Simeprevirdrug

150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 12 weeks in Arm 1.

Simeprevirdrug

150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 8 weeks in Arm 2

Sofosbuvirdrug

150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks in Arm 1.

Sofosbuvirdrug

150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 8 weeks in Arm 2.