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

PHASE3CompletedINTERVENTIONAL
Enrollment

534

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

October 31, 2014

Study Completion Date

December 31, 2014

Conditions
Chronic Hepatitis C
Interventions
DRUG

SOF

SOF 400 mg tablet administered orally once daily

DRUG

RBV

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)

DRUG

Peg-IFN

Peg-IFN 180 μg administered once weekly by subcutaneous injection

Trial Locations (175)

927

Fundacion De Investigacion De Diego, San Juan

1010

Auckland Clinical Studies, Grafton

1090

Medizinische Universität Wien, Vienna

1160

Wilhelminenspital, Vienna

2050

Royal Prince Alfred Hospital, Camperdown, NSW

2139

Concord Repatriation General Hospital, Concord

2145

Westmead Hospital, Westmead

2217

St George Hospital, Kogarah

2605

Canberra Hospital, Australian Capital Territory

3065

St. Vincent's Hospital, Fitzroy

3084

Austin Hospital, Heidelberg

3128

Box Hill Hospital, Victoria

3143

Tauranga Hospital, Tauranga

3168

Monash Medical Centre, Melbourne

3240

Waikato Hospital, Hamilton

4102

Princess Alexandra Hospital, State of Queensland

4120

Gallipoli Medical Research Foundation, Greenslopes

5000

Royal Adelaide Hospital, Adelaide

6000

Royal Perth Hospital, Perth Western Australia

6021

Wellington Hospital, Newtown

6160

B2 Clinic, Fremantle

8011

Christchurch Hospital, Christchurch

8035

Hospital Vall d'Hebron, Barcelona

8036

Medizinische Universität Graz, Graz

9016

Dunedin Hospital, Dunedin

10021

Weill Cornell Medical College, New York

10029

Mount Sinai School of Medicine, New York

10126

Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino, Turin

10617

West Tallinn Central Hospital, Tallinn

10969

Leber- und Studienzentrum am Checkpoint, Berlin

11030

North Shore University Hospital, Manhasset

11142

Auckland City Hospital, Auckland

13285

Hôpital Saint Joseph, Marseille

13353

Campus Virchow Klinikum, Berlin

13903

Binghamton Gastroenterology Associates, PC, Binghamton

15261

University of Pittsburgh, Pittsburgh

16128

Ente Ospedaliero Ospedali Galliera di Genova, Genoa

19104

Hospital of the University of Pennsylvania, Philadelphia

20009

Whitman-Walker Health, Washington D.C.

20099

Asklepios Klinik Sankt Georg Hamburg, Hamburg

20122

Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico, Milan

20162

Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milan

20246

Universitätsklinikum Hamburg Eppendorf, Hamburg

20502

Skånes Universitetssjukhus, Malmö, Malmo

21093

Johns Hopkins University, Lutherville

21229

Digestive Disease Associates, PA, Baltimore

22031

Metropolitan Research, Fairfax

22042

Inova Fairfax Hospital, Falls Church

23502

Digestive and Liver Disease Specialists, Norfolk

23602

Bon Secours Saint Mary's Hospital of Richmond, Newport News

24146

Leberstudienzentrum Kiel, Kiel

27103

Digestive Health Specialists, PA, Winston-Salem

27599

University of North Carolina, Chapel Hill

27710

Duke University Medical Center, Durham

28029

Hospital Carlos III, Madrid

28220

Hospital Puerta de Hierro Majadahonda, Majadahonda

28677

Carolinas Center for Liver Disease, Statesville

28801

Clinical Study Center of Asheville, LLC, Asheville

29010

Hospital Clinico Universitario Virgen de la Victoria, Málaga

30060

Gastointestinal Specialists of Georgia, PC, Marietta

30308

Atlanta Gastroenterology Associates, LLC, Atlanta

30309

Digestive Healthcare of Georgia, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

32256

Borland-Groover Clinic, Jacksonville

32610

University of Florida, Gainesville

32803

Orlando Immunology Center, Orlando

32806

Internal Medicine Specialists, Orlando

33136

University of Miami Center for Liver Diseases, Miami

33414

South Florida Center of Gastroenterology, PA., Wellington

33604

Hôpital Haut-Lévêque, CHU Bordeaux, Pessac

34209

Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases, Bradenton

34295

Hopital Saint Eloi, Montpellier

34655

Advanced Research Institute, Trinity

35033

Centre Hospitalier Universitare de Rennes, Hôpital Pontchaillou, Rennes

35128

Azienda Ospedaliera de Padova, Padua

35294

University of Alabama at Birmingham, Birmingham

37211

Nashville Medical Research Institute, Nashville

38138

Gastro One, Germantown

Memphis Gastroenterology Group, PC, Germantown

40225

Universitätsklinikum Düsseldorf, Düsseldorf

41014

Hospital Universitario Nuestra Señora de Valme, Seville

41685

Sahlgrenska University Hospital, Gothenburg

43126

Azienda Ospedaliero Universitaria di Parma, Parma

44623

Gastroenterologische Gemeinschaftspraxis, Herne

46010

Hospital General Universitario de Valencia, Valencia

46237

Indianapolis Gastroenterology Research Foundation, Indianapolis

48143

Centrum fur Interdisziplinare Medizin, Münster

48202

Henry Ford Health System, Detroit

48377

Orlando Clinical, Novi

50011

Ospedale S. Annunziata, Florence

51014

Tartu University Hospital, Tartu

53127

Universitätsklinikum Bonn, Bonn

54511

Hopital de I'Archet 2, Vandœuvre-lès-Nancy

55114

Minnesota Gastroenterology, P.A., Saint Paul

59037

Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie, Lille

60590

Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main, Frankfurt am Main

63003

Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand

CHU Estaing, Clermont-Ferrand

64131

Kansas City Gastroenterology and Hepatology, Kansas City

67091

Centre Hospitalier Universitaire de Strasbourg, Strasbourg

69120

Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankheiten, Heidelberg

71013

Casa Sollievo della Sofferenza Hospital, San Giovanni Rotonda

75246

Annette C. and Harold C. Simmons Transplant Center, Dallas

75571

Hôpital Saint-Antoine, Paris

75651

Groupe Hospitalier Pitié-Salpétrière, Paris

76012

Texas Clinical Research Institute, LLC, Arlington

77030

Research Specialists of Texas, Houston

78215

Alamo Medical Research, San Antonio

79098

PraxisZentrum für Gastroenterologie und Endokrinologie, Freiburg im Breisgau

80045

University of Colorado Hospital, Aurora

80113

South Denver Gastroenterology, PC, Englewood

81377

Klinikum der Universität München, Munich

90027

Kaiser Permanente, Los Angeles

90036

Lightsource Medical/Peter J. Ruane MD, Inc., Los Angeles

90048

California Liver Institute, Los Angeles

90069

Anthony Mills MD, Inc., Los Angeles

91942

eStudy Site, La Mesa

92056

eStudySite, Oceanside

92103

University of California, San Diego

92105

Resarch and Education, Inc., San Diego

92110

Hôpital Beaujon, Clichy

92118

Southern California Transplantation Institute, Research Foundation Liver Center, Coronado

92123

Medical Associates Research Group, San Diego

92154

Kaiser Permanente, San Diego

92324

Arrowhead Regional Medical Center, Colton

93301

Franco Felizarta, MD, Bakersfield

94010

Hôpital Henri Mondor, Créteil

94115

Quest Clinical Research, San Francisco

95817

University of California Davis Medical Center, Sacramento

97080

Universitatsklinikum Wurzburg, Würzburg

98111

Virginia Mason Medical Center, Seattle

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

01105

Infectious Disease and The Research Institute, Springfield

08844

ID Care, Inc., Hillsborough

08234

AGA Clinical Research Associates, LLC, Township

08360

The Gastroenterology Group of South Jersey, Vineland

02905

University Gastroenterology, Providence

QLD 4029

Royal Brisbane & Women's Hospital, Herston

T2N 4Z6

University of Calgary, Calgary

T6G 2B7

University of Alberta Hospital, Edmonton

V6Z 2C7

Vancouver Infectious Disease Research and Care Centre, Vancouver

V6Z 2K5

Gastrointestinal Research Institute (GIRI), Vancouver

R3A1R9

John Buhler Research Center, Winnipeg

M5G 1X5

Mount Sinai Hospital, Toronto

M5G 2C4

Toronto Western Hospital, Toronto

M5T 2S8

Toronto Western Hospital, Toronto

M6H 3M1

Toronto Liver Centre, Toronto

L4L 4Y7

Toronto Digestive Diseases Associates, Inc, Vaughan

H2X 3J4

Hopital St. Luc, Montreal

BC V5Z 1M9

Gordon & Leslie Diamond Health Care Centre, Vancouver

Unknown

Remedis s.r.o., Nestátní zdravotnické zarízení, Prague

06200

Service Hepatologie, Nice

04103

Universitätsklinikum Leipzig, Leipzig

00133

Fondazione PTV - Policlinico Tor Vergata, Roma

00149

I.N.M.I L. Spallanzani IRCCS, Rome

1105 AZ

Academisch Medisch Centrum, Amsterdam

6525 GA

Radboud University Nijmegen Medical Centre (UMC St Radboud), Nijmegen

3015 CE

Academic Hospital Rotterdam Erasmus Medical Center, Rotterdam

15-540

Klinika Chorob Zakaznych i Hep, Bialystok

41-500

Oddzial Kliniczny Chorob Zakaznych, Chorzów

91-347

WSSzpital im.Dr.Wj.Bieganskieg, Lodz

41-400

ID Clinic, Mysłowice

01-201

Sp Zoz Wojewódzki Szpital, Warsaw

08036

Hospital Casa de la Maternidad, Barcelona

141 86

Karolinska University Hospital Huddinge, Stockholm

W2 1NY

The Liver Unit, Paddington

B15 2TH

University of Birmingham, Birmingham

SO16 6YD

Southampton University Hospital, Hampshire

E1 1BB

London Royal Hospital, GHU, London

SE5 9RS

King's College Hospital, London

SW10 9NH

Chelsea and Westminster Hospital NHS Foundation Trust, London

UK NW3 2QG

Royal Free Hospital and University College London Hospital, London

M8 5RB

North Manchester General Hospital, Manchester

NG7 2UH

Nottingham University Hospitals-NHS, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

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 | Biotech Hunter | Biotech Hunter