Clinical trial NCT01625338: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: HCV genotype 2 (GT-2)
HCV genotype 3 (GT-3)
HCV
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
GS-7977
Ribavirin
Open Label
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-06-21
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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-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:

* 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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: Up to 24 weeks
measure: Percentage of Participants With Viral Relapse
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Bakersfield
country: United States
facility: Franco Felizarta, MD
state: California
city: Colton
country: United States
facility: Arrowhead Regional Medical Center
state: California
city: Coronado
country: United States
facility: Southern California Transplantation Institute, Research Foundation Liver Center
state: California
city: La Mesa
country: United States
facility: eStudy Site
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Los Angeles
country: United States
facility: Lightsource Medical/Peter J. Ruane MD, Inc.
state: California
city: Los Angeles
country: United States
facility: California Liver Institute
state: California
city: Los Angeles
country: United States
facility: Anthony Mills MD, Inc.
state: California
city: Oceanside
country: United States
facility: eStudySite
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Diego
country: United States
facility: University of California
state: California
city: San Diego
country: United States
facility: Resarch and Education, Inc.
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology, PC
state: Colorado
city: Washington
country: United States
facility: Whitman-Walker Health
state: District of Columbia
city: Bradenton
country: United States
facility: Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami Center for Liver Diseases
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Trinity
country: United States
facility: Advanced Research Institute
state: Florida
city: Wellington
country: United States
facility: South Florida Center of Gastroenterology, PA.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates, LLC
state: Georgia
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Marietta
country: United States
facility: Gastointestinal Specialists of Georgia, PC
state: Georgia
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: Baltimore
country: United States
facility: Digestive Disease Associates, PA
state: Maryland
city: Lutherville
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Infectious Disease and The Research Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Novi
country: United States
facility: Orlando Clinical
state: Michigan
city: St. Paul
country: United States
facility: Minnesota Gastroenterology, P.A.
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Gastroenterology and Hepatology
state: Missouri
city: Hillsborough
country: United States
facility: ID Care, Inc.
state: New Jersey
city: Township
country: United States
facility: AGA Clinical Research Associates, LLC
state: New Jersey
city: Vineland
country: United States
facility: The Gastroenterology Group of South Jersey
state: New Jersey
city: Binghamton
country: United States
facility: Binghamton Gastroenterology Associates, PC
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Asheville
country: United States
facility: Clinical Study Center of Asheville, LLC
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Statesville
country: United States
facility: Carolinas Center for Liver Disease
state: North Carolina
city: Winston Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Germantown
country: United States
facility: Memphis Gastroenterology Group, PC
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Dallas
country: United States
facility: Annette C. and Harold C. Simmons Transplant Center
state: Texas
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Newport News
country: United States
facility: Bon Secours Saint Mary's Hospital of Richmond
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Greenslopes
country: Australia
facility: Gallipoli Medical Research Foundation
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fremantle
country: Australia
facility: B2 Clinic
state: Western Australia
city: Australian Capital Territory
country: Australia
facility: Canberra Hospital
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
city: Kogarah
country: Australia
facility: St George Hospital
city: NSW
country: Australia
facility: Royal Prince Alfred Hospital, Camperdown
city: Perth Western Australia
country: Australia
facility: Royal Perth Hospital
city: State of Queensland
country: Australia
facility: Princess Alexandra Hospital
city: Victoria
country: Australia
facility: Box Hill Hospital
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Vienna
country: Austria
facility: Medizinische Universität Wien
city: Wien
country: Austria
facility: Wilhelminenspital
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Infectious Disease Research and Care Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Gastrointestinal Research Institute (GIRI)
state: British Columbia
city: Winnipeg
country: Canada
facility: John Buhler Research Center
state: Manitoba
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Diseases Associates, Inc
state: Ontario
city: Montreal
country: Canada
facility: Hopital St. Luc
state: Quebec
city: Vancouver
country: Canada
facility: Gordon & Leslie Diamond Health Care Centre
city: Praha 4
country: Czech Republic
facility: Remedis s.r.o., Nestátní zdravotnické zarízení
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Clichy
country: France
facility: Hôpital Beaujon
city: Creteil Cedex
country: France
facility: Hôpital Henri Mondor
city: Lille
country: France
facility: Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Montpellier
country: France
facility: Hopital Saint Eloi
city: Nice
country: France
facility: Service Hepatologie
city: Paris Cedex 12
country: France
facility: Hôpital Saint-Antoine
city: Paris Cedex 13
country: France
facility: Groupe Hospitalier Pitié-Salpétrière
city: Pessac Cedex
country: France
facility: Hôpital Haut-Lévêque, CHU Bordeaux
city: Rennes Cedex 9
country: France
facility: Centre Hospitalier Universitare de Rennes, Hôpital Pontchaillou
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg
city: Vandoeuvre-les-Nancy
country: France
facility: Hopital de I'Archet 2
city: Berlin
country: Germany
facility: Leber- und Studienzentrum am Checkpoint
city: Berlin
country: Germany
facility: Campus Virchow Klinikum
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Frankfurt am Main
country: Germany
facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
city: Freiburg im Breisgau
country: Germany
facility: PraxisZentrum für Gastroenterologie und Endokrinologie
city: Hamburg
country: Germany
facility: Asklepios Klinik Sankt Georg Hamburg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankheiten
city: Herne
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis
city: Kiel
country: Germany
facility: Leberstudienzentrum Kiel
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Muenster
country: Germany
facility: Centrum fur Interdisziplinare Medizin
city: Munich
country: Germany
facility: Klinikum der Universität München
city: Wurzburg
country: Germany
facility: Universitatsklinikum Wurzburg
city: San Giovanni Rotonda
country: Italy
facility: Casa Sollievo della Sofferenza Hospital
state: Foggia
city: Florence
country: Italy
facility: Ospedale S. Annunziata
city: Genoa
country: Italy
facility: Ente Ospedaliero Ospedali Galliera di Genova
city: Milano
country: Italy
facility: Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico
city: Milan
country: Italy
facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda
city: Padova
country: Italy
facility: Azienda Ospedaliera de Padova
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Roma
country: Italy
facility: Fondazione PTV - Policlinico Tor Vergata
city: Rome
country: Italy
facility: I.N.M.I L. Spallanzani IRCCS
city: Turin
country: Italy
facility: Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre (UMC St Radboud)
city: Rotterdam
country: Netherlands
facility: Academic Hospital Rotterdam Erasmus Medical Center
city: Grafton
country: New Zealand
facility: Auckland Clinical Studies
state: Auckland
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
state: BOP
city: Newtown
country: New Zealand
facility: Wellington Hospital
state: WGN
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Bialystok
country: Poland
facility: Klinika Chorob Zakaznych i Hep
city: Chorzow
country: Poland
facility: Oddzial Kliniczny Chorob Zakaznych
city: Lodz
country: Poland
facility: WSSzpital im.Dr.Wj.Bieganskieg
city: Myslowice
country: Poland
facility: ID Clinic
city: Warsaw
country: Poland
facility: Sp Zoz Wojewódzki Szpital
city: San Juan
country: Puerto Rico
facility: Fundacion De Investigacion De Diego
city: Barcelona
country: Spain
facility: Hospital Casa de la Maternidad
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Carlos III
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Señora de Valme
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Malmo
country: Sweden
facility: Skånes Universitetssjukhus, Malmö
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Paddington
country: United Kingdom
facility: The Liver Unit
state: London
city: Birmingham
country: United Kingdom
facility: University of Birmingham
city: Hampshire
country: United Kingdom
facility: Southampton University Hospital
city: London
country: United Kingdom
facility: London Royal Hospital, GHU
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Free Hospital and University College London Hospital
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals-NHS
Study officials:
affiliation: Gilead Sciences
name: Bittoo Kanwar, MD
role: STUDY_DIRECTOR
References: