CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
SOF +2 moredrug
Likely dose
RBV 200 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/NCT01958281
NCT01958281Phase 2Completed
CompareCT.gov

A Phase 2b, Open-Label Study of 200 mg or 400 mg Sofosbuvir+RBV for 24 Weeks in Genotype 1 or 3 and Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 Weeks in Genotype 1 or 4 HCV Infected Subjects With Renal Insufficiency

Gilead Sciences·interventional·Posted Oct 9, 2013·Updated Aug 8, 2018

In Brief

A Phase 2 clinical trial evaluating SOF, RBV, and 1 other intervention for HCV Infection. Completed, enrolled 38 participants across 10 sites in 3 countries.

Detailed Summary

The primary objectives of this study are to evaluate the safety and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) for 24 weeks and ledipasvir/sofosbuvir (LDV/SOF) for 12 weeks, and to evaluate the steady state pharmacokinetics (PK) of SOF and its metabolites and LDV in participants with genotype (GT) 1, 3, or 4 hepatitis C virus (HCV) infection who have chronic renal insufficiency (impaired kidney function).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHCV Infection
CountriesNew Zealand, Puerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 9, 2013
Enrollment StartOct 7, 2013
Primary CompletionJul 18, 2017
Study CompletionOct 19, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.7 years ago

Interventions

SOFdrug

Tablet(s) administered orally once daily

RBVdrug

200 mg tablet administered orally once daily

LDV/SOFdrug

90/400 mg fixed-dose combination (FDC) tablet administered orally once daily