NCT01740791

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	Velpatasvir	Tablets administered orally
DRUG	Placebo	Tablets administered orally

Timeline

• Start date: 2012-11-06
• Primary completion: 2013-03-15
• Completion: 2014-01-24
• First posted: 2012-12-04
• Last updated: 2020-12-16
• Results posted: 2020-12-16

Locations

10 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study