421
Participants
Start Date
September 30, 2012
Primary Completion Date
October 31, 2013
Study Completion Date
January 31, 2014
SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBV
Ribavirin (RBV) 200 mg 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)
Placebo to match SOF
Placebo to match SOF administered orally once daily
Placebo to match RBV
Placebo to match RBV administered orally in a divided daily dose
Fondazione PTV - Policlinico Tor Vergata, Roma
"INMI Lazzaro Spallanzani I.R.C.C.S.", Roma
Medizinische Universitat Wien, Vienna
Wilhelminenspital, Vienna
Universitaetsklinikum Leipzig, Leipzig
Hopital de l Archet 2, Nice
Azienda Ospedaliera Universitaria San Giovanni Battista di Torino, Torino
West Tallinn Central Hospital, Tallinn
Leber- and Studienzentrum am Checkpoint, Berlin
Hopital Saint Joseph, Marseille
Karolinska Instituet, Stockholm
Ente Ospedaliero Ospedali Galliera, Genova
Asklepios Klinik Sankt Georg H, Hamburg
Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico, Milan
Azienda Ospedaliera Ospedale Niguarda Cà Granda, Milan
Universitatsklinikum, Hamburg
Skanes Universitetssjukhus, Malmo
Skånes Universitetssjukhus, Lund, Lund
Leberstudienzentrum Kiel, Kiel
Hospital Carlos III, Madrid
Hospital Universitario La Paz, Madrid
Hospital Puerta de Hierro Maja, Majadahonda
Complejo Hospitalario de Especialidades Virgen de la Victoria, Málaga
Medizinische Hochschule Hannov, Hanover
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN, Pessac
Hopital Saint Eloi, Montpellier
CHU Pontchaillou - Hématologie Clinique, Rennes
University of Padova, Padua
Département Hépatogastroentérologie - CHU de Grenoble, Grenoble
Hospital Universitario Marques, Santander
Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi, Bologna
Heinrich Heine Unversitat, Düsseldorf
Valme Hospital, Seville
Sahlgrenska University Hospital, Gothenburg
Azienda Ospedaliero Universitaria di Parma, Parma
Gastroenterologische Gemeinsch, Herne
Hospital General Universitario de Valencia, Valencia
Ospedale S. Annunziata, Florence
Tartu University Hospital, Tartu
Universitaetsklinikum Bonn, Bonn
CHU de Nancy, Hôpital de Brabois, Vandœuvre-lès-Nancy
CHRU de Lille, Hopital Claude Huriez, CHRU Lille
JWG-Universität Frankfurt, Frankfurt am Main
CHU Estaing, Clermont-Ferrand
Centre Hospitalier Universitaire de Strasbourg, Strasbourg
Medizinische Klinik IV, Dep. o, Heidelberg
Ospedale Casa Sollievo, San Giovanni Rotondo
Hopital Saint Antoine, Paris
Hopital Pitie Salpetriere, Paris
Hopitaux Universitaires, Paris
Praxiszentrum, Freiburg im Breisgau
Klinikum der Universität Münch, München
University of Palermo, Palermo
Hopital Beaujon, Clichy
Hopital Henri Mondor, Créteil
Medizinische Universitat Graz, Graz
Centrum fuer interdisziplinaere Medizin Muenster GmbH, Münster
Academisch Medisch Centrum, Amsterdam
Leids Universitair Medisch Centrum, Leiden
UMC St. Radboud - Gastroenterology, Nijmegen
Erasmus MC, Rotterdam
Wojewodzki Szpital Specjalistyczny im Dluskeigo, Bialystok
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, Lodz
SP ZOZ Wojewodzki Szpital Zakazny w Warszawie, Warsaw
NZOZ Centrum Badan Klinicznych, Wroclaw
Hospital Universitari Vall d'H, Barcelona
Hospital Casa de la Maternidad, Barcelona
University of Birmingham, Edgbaston
Southampton University Hospital NHS Trust, Southhampton
King's College Hospital, Denmark Hill
The Liver Unit, Paddington
North Manchester General Hospital, Crumpsall
Bristol Royal Infirmary, Bristol
Queen Marys University of London, London
Royal Free Hospital and University College London Hospital, London
Chelsea & Westminster Hospital, London
Nottingham University Hospitals-NHS, Nottingham
Lead Sponsor
Gilead Sciences
INDUSTRY