CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 239 enrolled
Drug / intervention
LDV/SOF +2 moredrug
Likely dose
LDV/SOF 400 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/NCT02738333
NCT02738333Phase 3Completed
CompareCT.gov

A Phase 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection

Gilead Sciences·interventional·Posted Apr 14, 2016·Updated Nov 16, 2018

In Brief

A Phase 3 clinical trial evaluating LDV/SOF, SOF, and 1 other intervention for Hepatitis C Virus Infection. Completed, enrolled 239 participants across 37 sites.

Detailed Summary

The primary objectives of this study are to evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 14, 2016
Enrollment StartApr 12, 2016
Primary CompletionFeb 14, 2017
Study CompletionMay 11, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.2 years ago

Interventions

LDV/SOFdrug

90/400 mg FDC tablet administered orally once daily

SOFdrug

400 mg tablet administered orally once daily

RBVdrug

Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and \> 80 kg = 1000 mg)