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
- Registration Number
- NCT01625338
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 534
-
Infection with HCV
-
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
-
- Pregnant or nursing female or male with pregnant female partner
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOF+RBV 24 Weeks SOF SOF+RBV for 24 weeks SOF+RBV+Peg-IFN 12 Weeks Peg-IFN SOF+RBV+Peg-IFN for 12 weeks SOF+RBV+Peg-IFN 12 Weeks SOF SOF+RBV+Peg-IFN for 12 weeks SOF+RBV 12 Weeks SOF SOF+RBV for 12 weeks SOF+RBV 12 Weeks RBV SOF+RBV for 12 weeks SOF+RBV 24 Weeks RBV SOF+RBV for 24 weeks SOF+RBV+Peg-IFN 12 Weeks RBV SOF+RBV+Peg-IFN for 12 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) Posttreatment Week 12 SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event Up to 24 weeks
- Secondary Outcome Measures
Name Time Method Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) Posttreatment Weeks 4 and 24 SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With On-treatment Virologic Failure Up to 24 weeks On-treatment virologic failure was defined as
* Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or
* Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
* Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)Percentage of Participants With Viral Relapse Up to Posttreatment Week 24 Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
Trial Locations
- Locations (173)
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
Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases
🇺🇸Bradenton, Florida, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
Texas Clinical Research Institute, LLC
🇺🇸Arlington, Texas, United States
Research Specialists of Texas
🇺🇸Houston, Texas, United States
Annette C. and Harold C. Simmons Transplant Center
🇺🇸Dallas, Texas, United States
Arrowhead Regional Medical Center
🇺🇸Colton, California, United States
Franco Felizarta, MD
🇺🇸Bakersfield, California, United States
Southern California Transplantation Institute, Research Foundation Liver Center
🇺🇸Coronado, California, United States
eStudy Site
🇺🇸La Mesa, California, United States
eStudySite
🇺🇸Oceanside, California, United States
South Denver Gastroenterology, PC
🇺🇸Englewood, Colorado, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Advanced Research Institute
🇺🇸Trinity, Florida, United States
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
South Florida Center of Gastroenterology, PA.
🇺🇸Wellington, Florida, United States
Atlanta Gastroenterology Associates, LLC
🇺🇸Atlanta, Georgia, United States
Gastointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
Digestive Disease Associates, PA
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Johns Hopkins University
🇺🇸Lutherville, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Infectious Disease and The Research Institute
🇺🇸Springfield, Massachusetts, United States
Minnesota Gastroenterology, P.A.
🇺🇸St. Paul, Minnesota, United States
Orlando Clinical
🇺🇸Novi, Michigan, 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
Clinical Study Center of Asheville, LLC
🇺🇸Asheville, North Carolina, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Digestive Health Specialists, PA
🇺🇸Winston Salem, North Carolina, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Carolinas Center for Liver Disease
🇺🇸Statesville, North Carolina, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, 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
Gallipoli Medical Research Foundation
🇦🇺Greenslopes, Queensland, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Canberra Hospital
🇦🇺Australian Capital Territory, Australia
Royal Brisbane & Women's Hospital
🇦🇺Herston, Australia
St. Vincent's Hospital
🇦🇺Fitzroy, Australia
Royal Perth Hospital
🇦🇺Perth Western Australia, Australia
Royal Prince Alfred Hospital, Camperdown
🇦🇺NSW, Australia
Box Hill Hospital
🇦🇺Victoria, Australia
St George Hospital
🇦🇺Kogarah, Australia
Princess Alexandra Hospital
🇦🇺State of Queensland, Australia
Medizinische Universität Wien
🇦🇹Vienna, Austria
Medizinische Universität Graz
🇦🇹Graz, Austria
Wilhelminenspital
🇦🇹Wien, Austria
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Gastrointestinal Research Institute (GIRI)
🇨🇦Vancouver, British Columbia, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Toronto Liver Centre
🇨🇦Toronto, Ontario, Canada
Toronto Digestive Diseases Associates, Inc
🇨🇦Vaughan, Ontario, Canada
Hôpital Beaujon
🇫🇷Clichy, France
Gordon & Leslie Diamond Health Care Centre
🇨🇦Vancouver, Canada
Tartu University Hospital
🇪🇪Tartu, Estonia
Centre Hospitalier Universitaire de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
CHU Estaing
🇫🇷Clermont-Ferrand, France
Hôpital Henri Mondor
🇫🇷Creteil Cedex, France
Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie
🇫🇷Lille, France
Hopital Saint Eloi
🇫🇷Montpellier, France
Hôpital Saint Joseph
🇫🇷Marseille, France
Service Hepatologie
🇫🇷Nice, France
Hôpital Saint-Antoine
🇫🇷Paris Cedex 12, France
Groupe Hospitalier Pitié-Salpétrière
🇫🇷Paris Cedex 13, France
Hôpital Haut-Lévêque, CHU Bordeaux
🇫🇷Pessac Cedex, France
Centre Hospitalier Universitare de Rennes, Hôpital Pontchaillou
🇫🇷Rennes Cedex 9, France
Centre Hospitalier Universitaire de Strasbourg
🇫🇷Strasbourg, France
Hopital de I'Archet 2
🇫🇷Vandoeuvre-les-Nancy, France
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Campus Virchow Klinikum
🇩🇪Berlin, Germany
Asklepios Klinik Sankt Georg Hamburg
🇩🇪Hamburg, Germany
Leber- und Studienzentrum am Checkpoint
🇩🇪Berlin, Germany
Universitätsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
🇩🇪Frankfurt am Main, Germany
Leberstudienzentrum Kiel
🇩🇪Kiel, Germany
Gastroenterologische Gemeinschaftspraxis
🇩🇪Herne, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankheiten
🇩🇪Heidelberg, Germany
Centrum fur Interdisziplinare Medizin
🇩🇪Muenster, Germany
Casa Sollievo della Sofferenza Hospital
🇮🇹San Giovanni Rotonda, Foggia, Italy
Universitatsklinikum Wurzburg
🇩🇪Wurzburg, Germany
Klinikum der Universität München
🇩🇪Munich, Germany
Ospedale S. Annunziata
🇮🇹Florence, Italy
Ente Ospedaliero Ospedali Galliera di Genova
🇮🇹Genoa, Italy
Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
🇮🇹Milan, Italy
Azienda Ospedaliero Universitaria di Parma
🇮🇹Parma, Italy
Fondazione PTV - Policlinico Tor Vergata
🇮🇹Roma, Italy
I.N.M.I L. Spallanzani IRCCS
🇮🇹Rome, Italy
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Auckland Clinical Studies
🇳🇿Grafton, Auckland, New Zealand
Wellington Hospital
🇳🇿Newtown, WGN, New Zealand
Tauranga Hospital
🇳🇿Tauranga, BOP, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Auckland City Hospital
🇳🇿Auckland, New Zealand
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Klinika Chorob Zakaznych i Hep
🇵🇱Bialystok, Poland
Oddzial Kliniczny Chorob Zakaznych
🇵🇱Chorzow, Poland
Waikato Hospital
🇳🇿Hamilton, New Zealand
WSSzpital im.Dr.Wj.Bieganskieg
🇵🇱Lodz, Poland
Fundacion De Investigacion De Diego
🇵🇷San Juan, Puerto Rico
Hospital Casa de la Maternidad
🇪🇸Barcelona, Spain
Hospital Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Spain
Hospital Carlos III
🇪🇸Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Nuestra Señora de Valme
🇪🇸Sevilla, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Skånes Universitetssjukhus, Malmö
🇸🇪Malmo, Sweden
Southampton University Hospital
🇬🇧Hampshire, United Kingdom
The Liver Unit
🇬🇧Paddington, London, United Kingdom
London Royal Hospital, GHU
🇬🇧London, United Kingdom
University of Birmingham
🇬🇧Birmingham, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
North Manchester General Hospital
🇬🇧Manchester, United Kingdom
Nottingham University Hospitals-NHS
🇬🇧Nottingham, United Kingdom
Royal Free Hospital and University College London Hospital
🇬🇧London, United Kingdom
John Buhler Research Center
🇨🇦Winnipeg, Manitoba, Canada
B2 Clinic
🇦🇺Fremantle, Western Australia, Australia
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Kaiser Permanente
🇺🇸San Diego, 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
Quest Clinical Research
🇺🇸San Francisco, California, United States
University of Miami Center for Liver Diseases
🇺🇸Miami, Florida, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Nashville Medical Research Institute
🇺🇸Nashville, Tennessee, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
Karolinska University Hospital Huddinge
🇸🇪Stockholm, Sweden
Azienda Ospedaliera de Padova
🇮🇹Padova, Italy
Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino
🇮🇹Turin, Italy
PraxisZentrum für Gastroenterologie und Endokrinologie
🇩🇪Freiburg im Breisgau, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Indianapolis Gastroenterology Research Foundation
🇺🇸Indianapolis, Indiana, United States
ID Care, Inc.
🇺🇸Hillsborough, New Jersey, United States
Remedis s.r.o., Nestátní zdravotnické zarízení
🇨🇿Praha 4, Czech Republic
Academic Hospital Rotterdam Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
West Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Sp Zoz Wojewódzki Szpital
🇵🇱Warsaw, Poland
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
University of Florida
🇺🇸Gainesville, Florida, United States
Whitman-Walker Health
🇺🇸Washington, District of Columbia, United States
AGA Clinical Research Associates, LLC
🇺🇸Township, New Jersey, United States
Hopital St. Luc
🇨🇦Montreal, Quebec, Canada
Radboud University Nijmegen Medical Centre (UMC St Radboud)
🇳🇱Nijmegen, Netherlands
University of Calgary
🇨🇦Calgary, Alberta, Canada
Vancouver Infectious Disease Research and Care Centre
🇨🇦Vancouver, British Columbia, Canada
ID Clinic
🇵🇱Myslowice, Poland
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Internal Medicine Specialists
🇺🇸Orlando, Florida, United States
Kansas City Gastroenterology and Hepatology
🇺🇸Kansas City, Missouri, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Memphis Gastroenterology Group, PC
🇺🇸Germantown, Tennessee, United States
Monash Medical Centre
🇦🇺Melbourne, Victoria, Australia