NCT01965535 - Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection | Biotech Hunter

Enrollment

155

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

August 31, 2014

Study Completion Date

November 30, 2014

Conditions

HCV Infection

Interventions

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

Trial Locations (19)

13285

Marseille

31059

Toulouse

33604

Pessac

34295

Montpelier

35033

Rennes

38043

Grenoble

54500

Nancy

57037

Lille

63003

Clermont-Ferrand

67091

Strasbourg

69317

Lyon

75012

Paris

75013

Paris

75014

Paris

75020

Paris

87042

Limoges

92110

Clichy

94000

Créteil

06202

Nice