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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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SOF
RBV
Peg-IFN
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring HCV genotype 2 (GT-2), HCV genotype 3 (GT-3), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, GS-7977, Ribavirin, Open Label

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Franco Felizarta, MD
  • Arrowhead Regional Medical Center
  • Southern California Transplantation Institute, Research Foundation Liver Center
  • eStudy Site
  • Kaiser Permanente
  • Lightsource Medical/Peter J. Ruane MD, Inc.
  • California Liver Institute
  • Anthony Mills MD, Inc.
  • eStudySite
  • University of California Davis Medical Center
  • University of California
  • Resarch and Education, Inc.
  • Medical Associates Research Group
  • Kaiser Permanente
  • Quest Clinical Research
  • University of Colorado Hospital
  • South Denver Gastroenterology, PC
  • Whitman-Walker Health
  • Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases
  • University of Florida
  • Borland-Groover Clinic
  • University of Miami Center for Liver Diseases
  • Orlando Immunology Center
  • Internal Medicine Specialists
  • Advanced Research Institute
  • South Florida Center of Gastroenterology, PA.
  • Atlanta Gastroenterology Associates, LLC
  • Digestive Healthcare of Georgia
  • Gastointestinal Specialists of Georgia, PC
  • Indianapolis Gastroenterology Research Foundation
  • Digestive Disease Associates, PA
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Infectious Disease and The Research Institute
  • Henry Ford Health System
  • Orlando Clinical
  • Minnesota Gastroenterology, P.A.
  • Kansas City Gastroenterology and Hepatology
  • ID Care, Inc.
  • AGA Clinical Research Associates, LLC
  • The Gastroenterology Group of South Jersey
  • Binghamton Gastroenterology Associates, PC
  • North Shore University Hospital
  • Weill Cornell Medical College
  • Mount Sinai School of Medicine
  • Clinical Study Center of Asheville, LLC
  • University of North Carolina
  • Duke University Medical Center
  • Carolinas Center for Liver Disease
  • Digestive Health Specialists, PA
  • Hospital of the University of Pennsylvania
  • University of Pittsburgh
  • University Gastroenterology
  • Gastro One
  • Memphis Gastroenterology Group, PC
  • Nashville Medical Research Institute
  • Texas Clinical Research Institute, LLC
  • Annette C. and Harold C. Simmons Transplant Center
  • Research Specialists of Texas
  • Alamo Medical Research
  • Metropolitan Research
  • Inova Fairfax Hospital
  • Bon Secours Saint Mary's Hospital of Richmond
  • Digestive and Liver Disease Specialists
  • Virginia Mason Medical Center
  • Concord Repatriation General Hospital
  • Westmead Hospital
  • Gallipoli Medical Research Foundation
  • Royal Adelaide Hospital
  • Austin Hospital
  • Monash Medical Centre
  • B2 Clinic
  • Canberra Hospital
  • St. Vincent's Hospital
  • Royal Brisbane & Women's Hospital
  • St George Hospital
  • Royal Prince Alfred Hospital, Camperdown
  • Royal Perth Hospital
  • Princess Alexandra Hospital
  • Box Hill Hospital
  • Medizinische Universität Graz
  • Medizinische Universität Wien
  • Wilhelminenspital
  • University of Calgary
  • University of Alberta Hospital
  • Vancouver Infectious Disease Research and Care Centre
  • Gastrointestinal Research Institute (GIRI)
  • John Buhler Research Center
  • Mount Sinai Hospital
  • Toronto Western Hospital
  • Toronto Western Hospital
  • Toronto Liver Centre
  • Toronto Digestive Diseases Associates, Inc
  • Hopital St. Luc
  • Gordon & Leslie Diamond Health Care Centre
  • Remedis s.r.o., Nestátní zdravotnické zarízení
  • West Tallinn Central Hospital
  • Tartu University Hospital
  • Centre Hospitalier Universitaire de Clermont-Ferrand
  • CHU Estaing
  • Hôpital Beaujon
  • Hôpital Henri Mondor
  • Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie
  • Hôpital Saint Joseph
  • Hopital Saint Eloi
  • Service Hepatologie
  • Hôpital Saint-Antoine
  • Groupe Hospitalier Pitié-Salpétrière
  • Hôpital Haut-Lévêque, CHU Bordeaux
  • Centre Hospitalier Universitare de Rennes, Hôpital Pontchaillou
  • Centre Hospitalier Universitaire de Strasbourg
  • Hopital de I'Archet 2
  • Leber- und Studienzentrum am Checkpoint
  • Campus Virchow Klinikum
  • Universitätsklinikum Bonn
  • Universitätsklinikum Düsseldorf
  • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
  • PraxisZentrum für Gastroenterologie und Endokrinologie
  • Asklepios Klinik Sankt Georg Hamburg
  • Universitätsklinikum Hamburg Eppendorf
  • Medizinische Hochschule Hannover
  • Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankheiten
  • Gastroenterologische Gemeinschaftspraxis
  • Leberstudienzentrum Kiel
  • Universitätsklinikum Leipzig
  • Centrum fur Interdisziplinare Medizin
  • Klinikum der Universität München
  • Universitatsklinikum Wurzburg
  • Casa Sollievo della Sofferenza Hospital
  • Ospedale S. Annunziata
  • Ente Ospedaliero Ospedali Galliera di Genova
  • Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico
  • Azienda Ospedaliera Ospedale Niguarda Ca' Granda
  • Azienda Ospedaliera de Padova
  • Azienda Ospedaliero Universitaria di Parma
  • Fondazione PTV - Policlinico Tor Vergata
  • I.N.M.I L. Spallanzani IRCCS
  • Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino
  • Academisch Medisch Centrum
  • Radboud University Nijmegen Medical Centre (UMC St Radboud)
  • Academic Hospital Rotterdam Erasmus Medical Center
  • Auckland Clinical Studies
  • Tauranga Hospital
  • Wellington Hospital
  • Auckland City Hospital
  • Christchurch Hospital
  • Dunedin Hospital
  • Waikato Hospital
  • Klinika Chorob Zakaznych i Hep
  • Oddzial Kliniczny Chorob Zakaznych
  • WSSzpital im.Dr.Wj.Bieganskieg
  • ID Clinic
  • Sp Zoz Wojewódzki Szpital
  • Fundacion De Investigacion De Diego
  • Hospital Casa de la Maternidad
  • Hospital Vall d'Hebron
  • Hospital Carlos III
  • Hospital Puerta de Hierro Majadahonda
  • Hospital Clinico Universitario Virgen de la Victoria
  • Hospital Universitario Nuestra Señora de Valme
  • Hospital General Universitario de Valencia
  • Sahlgrenska University Hospital
  • Skånes Universitetssjukhus, Malmö
  • Karolinska University Hospital Huddinge
  • The Liver Unit
  • University of Birmingham
  • Southampton University Hospital
  • London Royal Hospital, GHU
  • King's College Hospital
  • Chelsea and Westminster Hospital NHS Foundation Trust
  • Royal Free Hospital and University College London Hospital
  • North Manchester General Hospital
  • Nottingham University Hospitals-NHS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

SOF+RBV 12 Weeks

SOF+RBV 24 Weeks

SOF+RBV+Peg-IFN 12 Weeks

Arm Description

SOF+RBV for 12 weeks

SOF+RBV for 24 weeks

SOF+RBV+Peg-IFN for 12 weeks

Outcomes

Primary Outcome Measures

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.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Secondary Outcome Measures

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
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
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
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.

Full Information

First Posted
June 7, 2012
Last Updated
October 9, 2015
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01625338
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
534 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOF+RBV 12 Weeks
Arm Type
Experimental
Arm Description
SOF+RBV for 12 weeks
Arm Title
SOF+RBV 24 Weeks
Arm Type
Experimental
Arm Description
SOF+RBV for 24 weeks
Arm Title
SOF+RBV+Peg-IFN 12 Weeks
Arm Type
Experimental
Arm Description
SOF+RBV+Peg-IFN for 12 weeks
Intervention Type
Drug
Intervention Name(s)
SOF
Other Intervention Name(s)
Sovaldi®, GS-7977, PSI-7977
Intervention Description
SOF 400 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Peg-IFN
Intervention Description
Peg-IFN 180 μg administered once weekly by subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Time Frame
Posttreatment Weeks 4 and 24
Title
Percentage of Participants With On-treatment Virologic Failure
Description
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)
Time Frame
Up to 24 weeks
Title
Percentage of Participants With Viral Relapse
Description
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.
Time Frame
Up to Posttreatment Week 24

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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