At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 273 enrolled
Drug / intervention
LDV/SOF +3 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.
A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
In Brief
A Phase 2 clinical trial evaluating LDV/SOF, RBV, and 2 other interventions for Chronic Hepatitis C. Completed, enrolled 273 participants across 2 sites.
Detailed Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesNew Zealand
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartAug 2014
Primary CompletionMar 2016
Study CompletionMay 2016
TodayJul 2026
First PostedJul 29, 2014
Enrollment StartAug 4, 2014
Primary CompletionMar 16, 2016
Study CompletionMay 9, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.9 years ago
Interventions
LDV/SOFdrug
90/400 mg FDC tablet administered orally once daily
RBVdrug
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
SOF/VELdrug
400/100 mg FDC tablet administered orally once daily
VOXdrug
100 mg tablet administered orally once daily with food