NCT01965535

Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks With Ribavirin or for 24 Weeks Without Ribavirin in Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to determine the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) with and without ribavirin (RBV), and to evaluate the safety and tolerability of each regimen as assessed by review of the accumulated safety data. Approximately 150 participants with genotype 1 HCV infection, who have previously received treatment for HCV, and who have a diagnosis for cirrhosis will be enrolled. Participants will be randomized to 1 of 2 groups. Group 1: SOF/LDV FDC tablet plus placebo to match RBV for 24 weeks Group 2: Delayed treatment group: placebo to match SOF/LDV FDC plus placebo to match RBV for 12 weeks, followed by SOF/LDV FDC once daily plus RBV in a divided daily dose for 12 weeks Randomization will 1:1 to the two groups and will be stratified by HCV genotype (1a, 1b; mixed or other genotype 1 results will be stratified as genotype 1a), and prior HCV therapy treatment response (never achieved HCV RNA \< the lower limit of quantitation (LLOQ), or achieved HCV RNA \< LLOQ).

Conditions

• HCV Infection

Interventions

Type	Name	Description
DRUG	LDV/SOF	LDV/SOF (90/400 mg) FDC tablet administered orally once daily
DRUG	RBV	RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg)
DRUG	Placebo to match LDV/SOF	Placebo to match LDV/SOF administered orally once daily
DRUG	Placebo to match RBV	Placebo to match RBV administered orally in a divided daily dose

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-08-01
• Completion: 2014-11-01
• First posted: 2013-10-18
• Last updated: 2018-11-16
• Results posted: 2015-09-28

Locations

19 sites across 1 country: France