Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
NCT ID: NCT01625338
Last Updated: 2015-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
534 participants
INTERVENTIONAL
2012-06-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SOF+RBV 12 Weeks
SOF+RBV for 12 weeks
SOF
SOF 400 mg tablet administered orally once daily
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)
SOF+RBV 24 Weeks
SOF+RBV for 24 weeks
SOF
SOF 400 mg tablet administered orally once daily
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)
SOF+RBV+Peg-IFN 12 Weeks
SOF+RBV+Peg-IFN for 12 weeks
SOF
SOF 400 mg tablet administered orally once daily
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)
Peg-IFN
Peg-IFN 180 μg administered once weekly by subcutaneous injection
Interventions
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SOF
SOF 400 mg tablet administered orally once daily
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)
Peg-IFN
Peg-IFN 180 μg administered once weekly by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have participated in a prior Gilead HCV study
* Use of highly effective contraception methods if female of childbearing potential or sexually active male
* Eligible patients include those in the following
* received placebo or Peg-IFN+RBV in a control arm
* previously participated in a Gilead-sponsored HCV study and did not attain sustained virologic response 24 weeks after discontinuation of therapy (SVR24) on a regimen containing:
* Sofosbuvir+RBV
* Peg-IFN and/or RBV in combination with one or more Gilead investigational direct-acting agents
Exclusion Criteria
* Current or prior history of clinical hepatic decompensation
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Chronic use of systemically administered immunosuppressive agents
* Active drug abuse
* Use of any prohibited concomitant medications
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Bittoo Kanwar, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Franco Felizarta, MD
Bakersfield, California, United States
Arrowhead Regional Medical Center
Colton, California, United States
Southern California Transplantation Institute, Research Foundation Liver Center
Coronado, California, United States
eStudy Site
La Mesa, California, United States
Kaiser Permanente
Los Angeles, California, United States
Lightsource Medical/Peter J. Ruane MD, Inc.
Los Angeles, California, United States
California Liver Institute
Los Angeles, California, United States
Anthony Mills MD, Inc.
Los Angeles, California, United States
eStudySite
Oceanside, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California
San Diego, California, United States
Resarch and Education, Inc.
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
Kaiser Permanente
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
South Denver Gastroenterology, PC
Englewood, Colorado, United States
Whitman-Walker Health
Washington D.C., District of Columbia, United States
Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases
Bradenton, Florida, United States
University of Florida
Gainesville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
University of Miami Center for Liver Diseases
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Internal Medicine Specialists
Orlando, Florida, United States
Advanced Research Institute
Trinity, Florida, United States
South Florida Center of Gastroenterology, PA.
Wellington, Florida, United States
Atlanta Gastroenterology Associates, LLC
Atlanta, Georgia, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, United States
Gastointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States
Digestive Disease Associates, PA
Baltimore, Maryland, United States
Johns Hopkins University
Lutherville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Infectious Disease and The Research Institute
Springfield, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Orlando Clinical
Novi, Michigan, United States
Minnesota Gastroenterology, P.A.
Saint Paul, Minnesota, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States
ID Care, Inc.
Hillsborough, New Jersey, United States
AGA Clinical Research Associates, LLC
Township, New Jersey, United States
The Gastroenterology Group of South Jersey
Vineland, New Jersey, United States
Binghamton Gastroenterology Associates, PC
Binghamton, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Weill Cornell Medical College
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Carolinas Center for Liver Disease
Statesville, North Carolina, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Gastro One
Germantown, Tennessee, United States
Memphis Gastroenterology Group, PC
Germantown, Tennessee, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
Annette C. and Harold C. Simmons Transplant Center
Dallas, Texas, United States
Research Specialists of Texas
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Bon Secours Saint Mary's Hospital of Richmond
Newport News, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
B2 Clinic
Fremantle, Western Australia, Australia
Canberra Hospital
Australian Capital Territory, , Australia
St. Vincent's Hospital
Fitzroy, , Australia
Royal Brisbane & Women's Hospital
Herston, , Australia
St George Hospital
Kogarah, , Australia
Royal Prince Alfred Hospital, Camperdown
NSW, , Australia
Royal Perth Hospital
Perth Western Australia, , Australia
Princess Alexandra Hospital
State of Queensland, , Australia
Box Hill Hospital
Victoria, , Australia
Medizinische Universität Graz
Graz, , Austria
Medizinische Universität Wien
Vienna, , Austria
Wilhelminenspital
Vienna, , Austria
University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver Infectious Disease Research and Care Centre
Vancouver, British Columbia, Canada
Gastrointestinal Research Institute (GIRI)
Vancouver, British Columbia, Canada
John Buhler Research Center
Winnipeg, Manitoba, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Toronto Digestive Diseases Associates, Inc
Vaughan, Ontario, Canada
Hopital St. Luc
Montreal, Quebec, Canada
Gordon & Leslie Diamond Health Care Centre
Vancouver, , Canada
Remedis s.r.o., Nestátní zdravotnické zarízení
Prague, , Czechia
West Tallinn Central Hospital
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, , France
CHU Estaing
Clermont-Ferrand, , France
Hôpital Beaujon
Clichy, , France
Hôpital Henri Mondor
Créteil, , France
Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie
Lille, , France
Hôpital Saint Joseph
Marseille, , France
Hopital Saint Eloi
Montpellier, , France
Service Hepatologie
Nice, , France
Hôpital Saint-Antoine
Paris, , France
Groupe Hospitalier Pitié-Salpétrière
Paris, , France
Hôpital Haut-Lévêque, CHU Bordeaux
Pessac, , France
Centre Hospitalier Universitare de Rennes, Hôpital Pontchaillou
Rennes, , France
Centre Hospitalier Universitaire de Strasbourg
Strasbourg, , France
Hopital de I'Archet 2
Vandœuvre-lès-Nancy, , France
Leber- und Studienzentrum am Checkpoint
Berlin, , Germany
Campus Virchow Klinikum
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, , Germany
PraxisZentrum für Gastroenterologie und Endokrinologie
Freiburg im Breisgau, , Germany
Asklepios Klinik Sankt Georg Hamburg
Hamburg, , Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankheiten
Heidelberg, , Germany
Gastroenterologische Gemeinschaftspraxis
Herne, , Germany
Leberstudienzentrum Kiel
Kiel, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Klinikum der Universität München
Munich, , Germany
Centrum fur Interdisziplinare Medizin
Münster, , Germany
Universitatsklinikum Wurzburg
Würzburg, , Germany
Casa Sollievo della Sofferenza Hospital
San Giovanni Rotonda, Foggia, Italy
Ospedale S. Annunziata
Florence, , Italy
Ente Ospedaliero Ospedali Galliera di Genova
Genoa, , Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, , Italy
Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera de Padova
Padua, , Italy
Azienda Ospedaliero Universitaria di Parma
Parma, , Italy
Fondazione PTV - Policlinico Tor Vergata
Roma, , Italy
I.N.M.I L. Spallanzani IRCCS
Rome, , Italy
Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino
Turin, , Italy
Academisch Medisch Centrum
Amsterdam, , Netherlands
Radboud University Nijmegen Medical Centre (UMC St Radboud)
Nijmegen, , Netherlands
Academic Hospital Rotterdam Erasmus Medical Center
Rotterdam, , Netherlands
Auckland Clinical Studies
Grafton, Auckland, New Zealand
Tauranga Hospital
Tauranga, BOP, New Zealand
Christchurch Hospital
Christchurch, Christchurch, New Zealand
Wellington Hospital
Newtown, WGN, New Zealand
Auckland City Hospital
Auckland, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Klinika Chorob Zakaznych i Hep
Bialystok, , Poland
Oddzial Kliniczny Chorob Zakaznych
Chorzów, , Poland
WSSzpital im.Dr.Wj.Bieganskieg
Lodz, , Poland
ID Clinic
Mysłowice, , Poland
Sp Zoz Wojewódzki Szpital
Warsaw, , Poland
Fundacion De Investigacion De Diego
San Juan, PR, Puerto Rico
Hospital Casa de la Maternidad
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Carlos III
Madrid, , Spain
Hospital Puerta de Hierro Majadahonda
Majadahonda, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Nuestra Señora de Valme
Seville, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Skånes Universitetssjukhus, Malmö
Malmo, , Sweden
Karolinska University Hospital Huddinge
Stockholm, , Sweden
The Liver Unit
Paddington, London, United Kingdom
University of Birmingham
Birmingham, , United Kingdom
Southampton University Hospital
Hampshire, , United Kingdom
London Royal Hospital, GHU
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, , United Kingdom
Royal Free Hospital and University College London Hospital
London, , United Kingdom
North Manchester General Hospital
Manchester, , United Kingdom
Nottingham University Hospitals-NHS
Nottingham, , United Kingdom
Countries
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Other Identifiers
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2012-000571-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-334-0109
Identifier Type: -
Identifier Source: org_study_id
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