NCT02120300

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

A Phase 2b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) in participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be enrolled.

Conditions

• Chronic HCV Infection

Interventions

Type	Name	Description
DRUG	LDV/SOF	90/400 mg FDC tablet administered orally
DRUG	SOF	400 mg tablet administered orally once daily
DRUG	RBV	Ribavirin (RBV) 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)

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2014-04-22
• Last updated: 2016-12-06
• Results posted: 2016-12-06

Locations

13 sites across 1 country: United States