CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 292 enrolled
Drug / intervention
SOF +5 moredrug
Likely dose
Not stated in 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/NCT01260350
NCT01260350Phase 2Completed
CompareCT.gov

A Multi-center, Open-Labeled Exploratory Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 400 mg and Ribavirin for 12 Weeks With and Without Pegylated Interferon in Treatment-Naïve Patients With Chronic HCV Infection Genotype 2 or Genotype 3

Gilead Sciences·interventional·Posted Dec 15, 2010·Updated Nov 17, 2014

In Brief

A Phase 2 clinical trial evaluating SOF, RBV, and 4 other interventions for Chronic Hepatitis C Infection. Completed, enrolled 292 participants across 2 sites.

Detailed Summary

This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Infection
CountriesNew Zealand
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2010
Enrollment StartDec 1, 2010
Primary CompletionOct 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.5 years ago

Interventions

SOFdrug

Sofosbuvir (SOF) tablets administered orally once daily

RBVdrug

Ribavirin (RBV) capsules administered orally in a divided daily dose

PEGdrug

Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly

LDVdrug

Ledipasvir (LDV) tablets administered orally once daily

GS-9669drug

GS-9669 tablets administered orally once daily

LDV/SOFdrug

LDV/SOF fixed-dose combination (FDC) tablet administered once daily