At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 103 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.
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-Naïve or -Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and Cirrhosis
In Brief
A Phase 3 clinical trial evaluating Simeprevir and Sofosbuvir for Hepatitis C Virus Infection. Completed, enrolled 103 participants across 34 sites in 2 countries.
Detailed Summary
The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with 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
Enrollment StartApr 2014
First PostedApr 2014
Primary CompletionJan 2015
Study CompletionApr 2015
TodayJul 2026
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
100 participants will receive 1 capsule of 150 mg orally once daily for 12 weeks.
Sofosbuvirdrug
100 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks.