Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis

PHASE2CompletedINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

July 29, 2016

Primary Completion Date

October 6, 2017

Study Completion Date

October 27, 2017

Conditions
Hepatitis C Virus Infection
Interventions
DRUG

SOF/VEL

400/100 mg FDC tablet administered orally once daily

DRUG

RBV

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)

Trial Locations (28)

8035

Hospital Universitario Valle Hebron, Barcelona

Unknown

Hospital Universitario Marques de Valdecilla, Santander

Hospital Universitario de A Coruña, A Coruña

Hospital Universitario Fundacion Alcorcon, Alcorcón

Hospital General Universitario De Alicante, Alicante

Complejo Hospitalario Torrecárdenas, Almería

Hospital Germans Trias i Pujol, Badalona

Hospital Clínic de Barcelona, Barcelona

Hospital del Mar, Barcelona

Hospital Universitari de Bellvitge, Barcelona

Servei de d'Aparell Digestiu Corporació Sanitària Parc Taulí, Barcelona

Reina Sofía University Hospital, Córdoba

Hospital Universitario Donostia, Donostia / San Sebastian

Hospital Puerta De Hierro Majadahonda, Madrid

Hospital Ramón y Cajal, Madrid

Hospital Universitario La Paz, Madrid

Hospital Universitario Virgen de la Victoria, Málaga

Hospital Universitario Virgen De La Arrixaca, Murcia

Hospital Universitario Central de asturias, Oviedo

Complexo Hospitalario Universitario de Montecelo, Pontevedra

Hospital Univ. NuestraSeñora Candelaria, Santa Cruz de Tenerife

Hospital de Valme, Seville

Hospital Universitario Virgen Del Rocio, Seville

Hospital Clinico Universitario, Valencia

Hospital General Valencia, Valencia

La Fe Hospital, Valencia

Hospital Universitario Alvaro Cunqueiro, Vigo

Hospital Clinico Universitario, Zaragoza

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT02781558 - Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis | Biotech Hunter | Biotech Hunter