Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

April 30, 2014

Study Completion Date

June 30, 2014

Conditions
Hepatitis C
Interventions
DRUG

SOF

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

DRUG

RBV

Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Trial Locations (16)

Unknown

Central Clinical Hospital of the Russian Academy of Sciences, Moscow

Central Scientific and Research Institute of Epidemiology of Rospotrebnadzor, Moscow

Central Scientific Research Institution of Gastroenterology of Moscow Healthcare Department, Moscow

City Clinical Hospital 24, Moscow

Clinical Diagnostics and Research Center of Federal Bedgetary Institution, Moscow

Infectious Clinical Hospital No. 1, Moscow

Institute of Nutrition of Academy of Sciences, Moscow

Institution of Healthcare of Sverdlovsk Region, Moscow

Institution of High Professional Education First Moscow State Medical University, Moscow

Institution of Tumen Region, Moscow

Krasnoyarsk Regional Center for Prevention and Control of AIDS and Infectious Diseases, Moscow

Scientific Research Institution of Emergency Care n.a. N.V. Sclifosovskiy of Moscow, Moscow

Stavropol State Medical University of Ministry of Healthcare, Moscow

Medical Military Academy n.a. S.M. Kirov, Saint Petersburg

Saint-Petersburg Center for Prevention and Control of AIDS and Infectious Diseases, Saint Petersburg

Medical Company Hepatolog, Samara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01896193 - Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection | Biotech Hunter | Biotech Hunter