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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01625338
First received: June 7, 2012
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) with or without peginterferon alfa-2a (PEG) in adults with chronic hepatitis C virus (HCV) who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).


Condition Intervention Phase
Chronic Hepatitis C
Drug: Sofosbuvir
Drug: RBV
Drug: PEG
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.

  • Any adverse event (AE) leading to permanent discontinuation of study drug [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants with sustained virologic response 4 and 24 weeks after discontinuation of treatment (SVR4 and SVR 24) [ Time Frame: Posttreatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR4 and SVR24 is defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

  • Proportion of participants with on-treatment virologic failure [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

    On-treatment virologic failure is defined as:

    • HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,
    • > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,
    • HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse)

  • Proportion of participants with virologic relapse [ Time Frame: Up to Posttreatment Week 24 ] [ Designated as safety issue: No ]
    Viral relapse is 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.


Enrollment: 533
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sofosbuvir+RBV 12 weeks
Participants will receive sofosbuvir+RBV for 12 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Experimental: Sofosbuvir+RBV 24 weeks
Participants will receive sofosbuvir+RBV for 24 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Experimental: Sofosbuvir+RBV+PEG 12 weeks
Participants will receive sofosbuvir+RBV+PEG for 12 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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+RBV in a control arm
    • previously participated in a Gilead-sponsored HCV study and did not attain SVR24 on a regimen containing:

      • Sofosbuvir+RBV
      • PEG and/or RBV in combination with one or more Gilead investigational direct-acting agents

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625338

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Franco Felizarta, MD
Bakersfield, California, United States, 93301
Arrowhead Regional Medical Center
Colton, California, United States, 92324
Southern California Transplantation Institute, Research Foundation Liver Center
Coronado, California, United States, 92118
eStudy Site
La Mesa, California, United States, 91942
Kaiser Permanente
Los Angeles, California, United States, 90027
Anthony Mills MD, Inc.
Los Angeles, California, United States, 90069
California Liver Institute
Los Angeles, California, United States, 90048
Lightsource Medical/Peter J. Ruane MD, Inc.
Los Angeles, California, United States, 90036
eStudySite
Oceanside, California, United States, 92056
University of California Davis Medical Center
Sacramento, California, United States, 95817
Medical Associates Research Group
San Diego, California, United States, 92123
Kaiser Permanente
San Diego, California, United States, 92154
University of California
San Diego, California, United States, 92103
Resarch and Education, Inc.
San Diego, California, United States, 92105
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
South Denver Gastroenterology, PC
Englewood, Colorado, United States, 80113
United States, District of Columbia
Whitman-Walker Health
Washington, District of Columbia, United States, 20009
United States, Florida
Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases
Bradenton, Florida, United States, 34209
University of Florida
Gainesville, Florida, United States, 32610
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
University of Miami Center for Liver Diseases
Miami, Florida, United States, 33136
Orlando Immunology Center
Orlando, Florida, United States, 32803
Internal Medicine Specialists
Orlando, Florida, United States, 32806
Advanced Research Institute
Trinity, Florida, United States, 34655
South Florida Center of Gastroenterology, PA.
Wellington, Florida, United States, 33414
United States, Georgia
Atlanta Gastroenterology Associates, LLC
Atlanta, Georgia, United States, 30308
Digestive Healthcare of Georgia
Atlanta, Georgia, United States, 30309
Gastointestinal Specialists of Georgia, PC
Marietta, Georgia, United States, 30060
United States, Indiana
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States, 46237
United States, Maryland
Digestive Disease Associates, PA
Baltimore, Maryland, United States, 21229
Johns Hopkins University
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Infectious Disease and The Research Institute
Springfield, Massachusetts, United States, 01105
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Orlando Clinical
Novi, Michigan, United States, 48377
United States, Minnesota
Minnesota Gastroenterology, P.A.
St. Paul, Minnesota, United States, 55114
United States, Missouri
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States, 64131
United States, New Jersey
ID Care, Inc.
Hillsborough, New Jersey, United States, 08844
AGA Clinical Research Associates, LLC
Township, New Jersey, United States, 08234
The Gastroenterology Group of South Jersey
Vineland, New Jersey, United States, 08360
United States, New York
Binghamton Gastroenterology Associates, PC
Binghamton, New York, United States, 13903
North Shore University Hospital
Manhasset, New York, United States, 11030
Mount Sinai School of Medicine
New York, New York, United States, 10029
Weill Cornell Medical College
New York, New York, United States, 10021
United States, North Carolina
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, United States, 28801
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
Carolinas Center for Liver Disease
Statesville, North Carolina, United States, 28677
Digestive Health Specialists, PA
Winston Salem, North Carolina, United States, 27103
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
United States, Rhode Island
University Gastroenterology
Providence, Rhode Island, United States, 02905
United States, Tennessee
Gastro One
Germantown, Tennessee, United States, 38138
Memphis Gastroenterology Group, PC
Germantown, Tennessee, United States, 38138
Nashville Medical Research Institute
Nashville, Tennessee, United States, 37211
United States, Texas
Texas Clinical Research Institute, LLC
Arlington, Texas, United States, 76012
Annette C. and Harold C. Simmons Transplant Center
Dallas, Texas, United States, 75246
Research Specialists of Texas
Houston, Texas, United States, 77030
Alamo Medical Research
San Antonio, Texas, United States, 78215
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Bon Secours Saint Mary's Hospital of Richmond
Newport News, Virginia, United States, 23602
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Australia, New South Wales
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia, 4120
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Australia, Western Australia
B2 Clinic
Fremantle, Western Australia, Australia, 6160
Australia
Canberra Hospital
Australian Capital Territory, Australia, 2605
St. Vincent's Hospital
Fitzroy, Australia, 3065
Royal Brisbane & Women's Hospital
Herston, Australia, QLD 4029
St George Hospital
Kogarah, Australia, 2217
Royal Prince Alfred Hospital, Camperdown
NSW, Australia, 2050
Royal Perth Hospital
Perth Western Australia, Australia, 6000
Princess Alexandra Hospital
State of Queensland, Australia, 4102
Box Hill Hospital
Victoria, Australia, 3128
Austria
Medizinische Universität Graz
Graz, Austria, 8036
Medizinische Universität Wien
Vienna, Austria, 1090
Wilhelminenspital
Wien, Austria, 1160
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver Infectious Disease Research and Care Centre
Vancouver, British Columbia, Canada, V6Z 2C7
Gastrointestinal Research Institute (GIRI)
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Manitoba
John Buhler Research Center
Winnipeg, Manitoba, Canada, R3A1R9
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5G 2C4
Toronto Liver Centre
Toronto, Ontario, Canada, M6H 3M1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Toronto Digestive Diseases Associates, Inc
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
Hopital St. Luc
Montreal, Quebec, Canada, H2X 3J4
Canada
Gordon & Leslie Diamond Health Care Centre
Vancouver, Canada, BC V5Z 1M9
Czech Republic
Remedis s.r.o., Nestátní zdravotnické zarízení
Praha 4, Czech Republic
Estonia
West Tallinn Central Hospital
Tallinn, Estonia, 10617
Tartu University Hospital
Tartu, Estonia, 51014
France
CHU Estaing
Clermont-Ferrand, France, 63003
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France, 63003
Hôpital Beaujon
Clichy, France, 92110
Hôpital Henri Mondor
Creteil Cedex, France, 94010
Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie
Lille, France, 59037
Hôpital Saint Joseph
Marseille, France, 13285
Hopital Saint Eloi
Montpellier, France, 34295
Service Hepatologie
Nice, France, 06200
Hôpital Saint-Antoine
Paris Cedex 12, France, 75571
Groupe Hospitalier Pitié-Salpétrière
Paris Cedex 13, France, 75651
Hôpital Haut-Lévêque, CHU Bordeaux
Pessac Cedex, France, 33604
Centre Hospitalier Universitare de Rennes, Hôpital Pontchaillou
Rennes Cedex 9, France, 35033
Centre Hospitalier Universitaire de Strasbourg
Strasbourg, France, 67091
Hopital de I'Archet 2
Vandoeuvre-les-Nancy, France, 54511
Germany
Campus Virchow Klinikum
Berlin, Germany, 13353
Leber- und Studienzentrum am Checkpoint
Berlin, Germany, 10969
Universitätsklinikum Bonn
Bonn, Germany, 53127
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, Germany, 60590
PraxisZentrum für Gastroenterologie und Endokrinologie
Freiburg im Breisgau, Germany, 79098
Asklepios Klinik Sankt Georg Hamburg
Hamburg, Germany, 20099
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankheiten
Heidelberg, Germany, 69120
Gastroenterologische Gemeinschaftspraxis
Herne, Germany, 44623
Leberstudienzentrum Kiel
Kiel, Germany, 24146
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Centrum fur Interdisziplinare Medizin
Muenster, Germany, 48143
Klinikum der Universität München
Munich, Germany, 81377
Universitatsklinikum Wurzburg
Wurzburg, Germany, 97080
Italy
Casa Sollievo della Sofferenza Hospital
San Giovanni Rotonda, Foggia, Italy, 71013
Ospedale S. Annunziata
Florence, Italy, 50011
Ente Ospedaliero Ospedali Galliera di Genova
Genoa, Italy, 16128
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, Italy, 20162
Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico
Milano, Italy, 20122
Azienda Ospedaliera de Padova
Padova, Italy, 35128
Azienda Ospedaliero Universitaria di Parma
Parma, Italy, 43126
Fondazione PTV - Policlinico Tor Vergata
Roma, Italy, 00133
I.N.M.I L. Spallanzani IRCCS
Rome, Italy, 00149
Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino
Turin, Italy, 10126
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Radboud University Nijmegen Medical Centre (UMC St Radboud)
Nijmegen, Netherlands, 6525 GA
Academic Hospital Rotterdam Erasmus Medical Center
Rotterdam, Netherlands, 3015 CE
New Zealand
Auckland Clinical Studies
Grafton, Auckland, New Zealand, 1010
Tauranga Hospital
Tauranga, BOP, New Zealand, 3143
Wellington Hospital
Newtown, WGN, New Zealand, 6021
Auckland City Hospital
Auckland, New Zealand, 11142
Christchurch Hospital
Christchurch, New Zealand, 8011
Dunedin Hospital
Dunedin, New Zealand, 9016
Waikato Hospital
Hamilton, New Zealand, 3240
Poland
Klinika Chorob Zakaznych i Hep
Bialystok, Poland, 15-540
Oddzial Kliniczny Chorob Zakaznych
Chorzow, Poland, 41-500
WSSzpital im.Dr.Wj.Bieganskieg
Lodz, Poland, 91-347
ID Clinic
Myslowice, Poland, 41-400
Sp Zoz Wojewódzki Szpital
Warsaw, Poland, 01-201
Puerto Rico
Fundacion De Investigacion De Diego
San Juan, Puerto Rico, 927
Spain
Hospital Casa de la Maternidad
Barcelona, Spain, 08036
Hospital Vall d'Hebron
Barcelona, Spain, 8035
Hospital Carlos III
Madrid, Spain, 28029
Hospital Puerta de Hierro Majadahonda
Majadahonda, Spain, 28220
Hospital Clinico Universitario Virgen de la Victoria
Malaga, Spain, 29010
Hospital Universitario Nuestra Señora de Valme
Sevilla, Spain, 41014
Hospital General Universitario de Valencia
Valencia, Spain, 46010
Sweden
Sahlgrenska University Hospital
Göteborg, Sweden, 41685
Skånes Universitetssjukhus, Malmö
Malmo, Sweden, 20502
Karolinska University Hospital Huddinge
Stockholm, Sweden, 141 86
United Kingdom
The Liver Unit
Paddington, London, United Kingdom, W2 1NY
University of Birmingham
Birmingham, United Kingdom, B15 2TH
Southampton University Hospital
Hampshire, United Kingdom, SO16 6YD
Chelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom, SW10 9NH
King's College Hospital
London, United Kingdom, SE5 9RS
London Royal Hospital, GHU
London, United Kingdom, E1 1BB
Royal Free Hospital and University College London Hospital
London, United Kingdom, UK NW3 2QG
North Manchester General Hospital
Manchester, United Kingdom, M8 5RB
Nottingham University Hospitals-NHS
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Bittoo Kanwar, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01625338     History of Changes
Other Study ID Numbers: GS-US-334-0109, 2012-000571-16
Study First Received: June 7, 2012
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Office for Safety in Health Care
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
Italy: Ethics Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Estonia: The State Agency of Medicine
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Gilead Sciences:
HCV genotype 2 (GT-2)
HCV genotype 3 (GT-3)
HCV
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
GS-7977
Ribavirin
Open Label

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014