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
An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
2 other identifiers
interventional
534
14 countries
158
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2012
158 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
June 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
November 9, 2015
CompletedNovember 9, 2015
October 1, 2015
2.3 years
June 7, 2012
October 9, 2015
October 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to 24 weeks
Secondary Outcomes (3)
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
Percentage of Participants With On-treatment Virologic Failure
Up to 24 weeks
Percentage of Participants With Viral Relapse
Up to Posttreatment Week 24
Study Arms (3)
SOF+RBV 12 Weeks
EXPERIMENTALSOF+RBV for 12 weeks
SOF+RBV 24 Weeks
EXPERIMENTALSOF+RBV for 24 weeks
SOF+RBV+Peg-IFN 12 Weeks
EXPERIMENTALSOF+RBV+Peg-IFN for 12 weeks
Interventions
SOF 400 mg tablet administered orally once daily
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 180 μg administered once weekly by subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (175)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Franco Felizarta, MD
Bakersfield, California, 93301, United States
Arrowhead Regional Medical Center
Colton, California, 92324, United States
Southern California Transplantation Institute, Research Foundation Liver Center
Coronado, California, 92118, United States
eStudy Site
La Mesa, California, 91942, United States
Kaiser Permanente
Los Angeles, California, 90027, United States
Lightsource Medical/Peter J. Ruane MD, Inc.
Los Angeles, California, 90036, United States
California Liver Institute
Los Angeles, California, 90048, United States
Anthony Mills MD, Inc.
Los Angeles, California, 90069, United States
eStudySite
Oceanside, California, 92056, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
University of California
San Diego, California, 92103, United States
Resarch and Education, Inc.
San Diego, California, 92105, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Kaiser Permanente
San Diego, California, 92154, United States
Quest Clinical Research
San Francisco, California, 94115, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
South Denver Gastroenterology, PC
Englewood, Colorado, 80113, United States
Whitman-Walker Health
Washington D.C., District of Columbia, 20009, United States
Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases
Bradenton, Florida, 34209, United States
University of Florida
Gainesville, Florida, 32610, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
University of Miami Center for Liver Diseases
Miami, Florida, 33136, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Internal Medicine Specialists
Orlando, Florida, 32806, United States
Advanced Research Institute
Trinity, Florida, 34655, United States
South Florida Center of Gastroenterology, PA.
Wellington, Florida, 33414, United States
Atlanta Gastroenterology Associates, LLC
Atlanta, Georgia, 30308, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
Gastointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237, United States
Digestive Disease Associates, PA
Baltimore, Maryland, 21229, United States
Johns Hopkins University
Lutherville, Maryland, 21093, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Infectious Disease and The Research Institute
Springfield, Massachusetts, 01105, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Orlando Clinical
Novi, Michigan, 48377, United States
Minnesota Gastroenterology, P.A.
Saint Paul, Minnesota, 55114, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, 64131, United States
ID Care, Inc.
Hillsborough, New Jersey, 08844, United States
AGA Clinical Research Associates, LLC
Township, New Jersey, 08234, United States
The Gastroenterology Group of South Jersey
Vineland, New Jersey, 08360, United States
Binghamton Gastroenterology Associates, PC
Binghamton, New York, 13903, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, 28801, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Carolinas Center for Liver Disease
Statesville, North Carolina, 28677, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Gastro One
Germantown, Tennessee, 38138, United States
Memphis Gastroenterology Group, PC
Germantown, Tennessee, 38138, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37211, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
Annette C. and Harold C. Simmons Transplant Center
Dallas, Texas, 75246, United States
Research Specialists of Texas
Houston, Texas, 77030, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Bon Secours Saint Mary's Hospital of Richmond
Newport News, Virginia, 23602, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Virginia Mason Medical Center
Seattle, Washington, 98111, United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, 4120, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Monash Medical Centre
Melbourne, Victoria, 3168, Australia
B2 Clinic
Fremantle, Western Australia, 6160, Australia
Canberra Hospital
Australian Capital Territory, 2605, Australia
St. Vincent's Hospital
Fitzroy, 3065, Australia
Royal Brisbane & Women's Hospital
Herston, QLD 4029, Australia
St George Hospital
Kogarah, 2217, Australia
Royal Prince Alfred Hospital, Camperdown
NSW, 2050, Australia
Royal Perth Hospital
Perth Western Australia, 6000, Australia
Princess Alexandra Hospital
State of Queensland, 4102, Australia
Box Hill Hospital
Victoria, 3128, Australia
Medizinische Universität Graz
Graz, 8036, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Wilhelminenspital
Vienna, 1160, Austria
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Vancouver Infectious Disease Research and Care Centre
Vancouver, British Columbia, V6Z 2C7, Canada
Gastrointestinal Research Institute (GIRI)
Vancouver, British Columbia, V6Z 2K5, Canada
John Buhler Research Center
Winnipeg, Manitoba, R3A1R9, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Toronto Western Hospital
Toronto, Ontario, M5G 2C4, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Toronto Liver Centre
Toronto, Ontario, M6H 3M1, Canada
Toronto Digestive Diseases Associates, Inc
Vaughan, Ontario, L4L 4Y7, Canada
Hopital St. Luc
Montreal, Quebec, H2X 3J4, Canada
Gordon & Leslie Diamond Health Care Centre
Vancouver, BC V5Z 1M9, Canada
Remedis s.r.o., Nestátní zdravotnické zarízení
Prague, Czechia
West Tallinn Central Hospital
Tallinn, 10617, Estonia
Tartu University Hospital
Tartu, 51014, Estonia
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63003, France
CHU Estaing
Clermont-Ferrand, 63003, France
Hôpital Beaujon
Clichy, 92110, France
Hôpital Henri Mondor
Créteil, 94010, France
Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie
Lille, 59037, France
Hôpital Saint Joseph
Marseille, 13285, France
Hopital Saint Eloi
Montpellier, 34295, France
Service Hepatologie
Nice, 06200, France
Hôpital Saint-Antoine
Paris, 75571, France
Groupe Hospitalier Pitié-Salpétrière
Paris, 75651, France
Hôpital Haut-Lévêque, CHU Bordeaux
Pessac, 33604, France
Centre Hospitalier Universitare de Rennes, Hôpital Pontchaillou
Rennes, 35033, France
Centre Hospitalier Universitaire de Strasbourg
Strasbourg, 67091, France
Hopital de I'Archet 2
Vandœuvre-lès-Nancy, 54511, France
Leber- und Studienzentrum am Checkpoint
Berlin, 10969, Germany
Campus Virchow Klinikum
Berlin, 13353, Germany
Universitätsklinikum Bonn
Bonn, 53127, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, 60590, Germany
PraxisZentrum für Gastroenterologie und Endokrinologie
Freiburg im Breisgau, 79098, Germany
Asklepios Klinik Sankt Georg Hamburg
Hamburg, 20099, Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankheiten
Heidelberg, 69120, Germany
Gastroenterologische Gemeinschaftspraxis
Herne, 44623, Germany
Leberstudienzentrum Kiel
Kiel, 24146, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Klinikum der Universität München
Munich, 81377, Germany
Centrum fur Interdisziplinare Medizin
Münster, 48143, Germany
Universitatsklinikum Wurzburg
Würzburg, 97080, Germany
Casa Sollievo della Sofferenza Hospital
San Giovanni Rotonda, Foggia, 71013, Italy
Ospedale S. Annunziata
Florence, 50011, Italy
Ente Ospedaliero Ospedali Galliera di Genova
Genoa, 16128, Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, 20162, Italy
Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico
Milan, 20122, Italy
Azienda Ospedaliera de Padova
Padua, 35128, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, 43126, Italy
Fondazione PTV - Policlinico Tor Vergata
Roma, 00133, Italy
I.N.M.I L. Spallanzani IRCCS
Rome, 00149, Italy
Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino
Turin, 10126, Italy
Academisch Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
Radboud University Nijmegen Medical Centre (UMC St Radboud)
Nijmegen, 6525 GA, Netherlands
Academic Hospital Rotterdam Erasmus Medical Center
Rotterdam, 3015 CE, Netherlands
Auckland Clinical Studies
Grafton, Auckland, 1010, New Zealand
Tauranga Hospital
Tauranga, BOP, 3143, New Zealand
Christchurch Hospital
Christchurch, Christchurch, 8011, New Zealand
Wellington Hospital
Newtown, WGN, 6021, New Zealand
Auckland City Hospital
Auckland, 11142, New Zealand
Dunedin Hospital
Dunedin, 9016, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
Klinika Chorob Zakaznych i Hep
Bialystok, 15-540, Poland
Oddzial Kliniczny Chorob Zakaznych
Chorzów, 41-500, Poland
WSSzpital im.Dr.Wj.Bieganskieg
Lodz, 91-347, Poland
ID Clinic
Mysłowice, 41-400, Poland
Sp Zoz Wojewódzki Szpital
Warsaw, 01-201, Poland
Fundacion De Investigacion De Diego
San Juan, PR, 927, Puerto Rico
Hospital Casa de la Maternidad
Barcelona, 08036, Spain
Hospital Vall d'Hebron
Barcelona, 8035, Spain
Hospital Carlos III
Madrid, 28029, Spain
Hospital Puerta de Hierro Majadahonda
Majadahonda, 28220, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario Nuestra Señora de Valme
Seville, 41014, Spain
Hospital General Universitario de Valencia
Valencia, 46010, Spain
Sahlgrenska University Hospital
Gothenburg, 41685, Sweden
Skånes Universitetssjukhus, Malmö
Malmo, 20502, Sweden
Karolinska University Hospital Huddinge
Stockholm, 141 86, Sweden
The Liver Unit
Paddington, London, W2 1NY, United Kingdom
University of Birmingham
Birmingham, B15 2TH, United Kingdom
Southampton University Hospital
Hampshire, SO16 6YD, United Kingdom
London Royal Hospital, GHU
London, E1 1BB, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH, United Kingdom
Royal Free Hospital and University College London Hospital
London, UK NW3 2QG, United Kingdom
North Manchester General Hospital
Manchester, M8 5RB, United Kingdom
Nottingham University Hospitals-NHS
Nottingham, NG7 2UH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
There were no limitations affecting the analysis or results.
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Bittoo Kanwar, MD
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2012
First Posted
June 21, 2012
Study Start
June 1, 2012
Primary Completion
October 1, 2014
Study Completion
December 1, 2014
Last Updated
November 9, 2015
Results First Posted
November 9, 2015
Record last verified: 2015-10