At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 41 enrolled

Drug / intervention

Simeprevir (SMV) +2 moredrug

Likely dose

Simeprevir (SMV) 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/NCT02421211

NCT02421211Phase 2Completed

Compare CT.gov

A Phase 2, 2-panel, Open-label Randomized Study in Hepatitis C Virus Infected Subjects to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir and Ledipasvir in Treatment-naive Participants.

Janssen Sciences Ireland UC·interventional·Posted Apr 20, 2015·Updated Mar 28, 2019

In Brief

A Phase 2 clinical trial evaluating Simeprevir (SMV), Ledipasvir (LDV), and 1 other intervention for Hepatitis C, Chronic. Completed, enrolled 41 participants across 4 sites.

Detailed Summary

The purpose of this study is to evaluate the pharmacokinetic interactions between simeprevir and ledipasvir in a treatment regimen consisting of simeprevir (SMV), sofosbuvir (SOF), and ledipasvir (LDV) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype 1 infection.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis C, Chronic

CountriesBelgium

Collaborators--

Timeline

Phase 2CompletedFinished

201520162017201820192020202120222023202420252026

First PostedApr 2015

Enrollment StartMay 2015

Primary CompletionNov 2015

Study CompletionJan 2016

TodayJul 2026

First PostedApr 20, 2015

Enrollment StartMay 19, 2015

Primary CompletionNov 10, 2015

Study CompletionJan 27, 2016

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 11.2 years ago

Interventions

Simeprevir (SMV)drug

Participants will receive 150 milligram (mg) of SMV (Treatment A) once daily in Panel 1 and Panel 2.

Ledipasvir (LDV)drug

Participants will receive 90 mg of LDV once daily as FDC tablet with SOF (Treatment B) in Panel 1 and Panel 2.

Sofosbuvir (SOF)drug

Participants will receive 400 mg of SOF alone (Treatment C) in Panel 1 and as FDC tablet with LDV (Treatment B) once daily in Panel 2.