At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 103 enrolled
Drug / intervention
Velpatasvir +1 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.
Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-5816 in Subjects With Chronic Hepatitis C Virus Infection
In Brief
A Phase 1 clinical trial evaluating Velpatasvir and Placebo for Chronic Hepatitis C Virus. Completed, enrolled 103 participants across 10 sites in 2 countries.
Detailed Summary
The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Virus
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedDec 2012
Primary CompletionMar 2013
Study CompletionJan 2014
TodayJul 2026
First PostedDec 4, 2012
Enrollment StartNov 6, 2012
Primary CompletionMar 15, 2013
Study CompletionJan 24, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.6 years ago
Interventions
Velpatasvirdrug
Tablets administered orally
Placebodrug
Tablets administered orally