A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

TerminatedOBSERVATIONAL
Enrollment

1,609

Participants

Timeline

Start Date

December 29, 2014

Primary Completion Date

December 31, 2021

Study Completion Date

December 31, 2021

Conditions
Hepatitis C Virus Infection
Interventions
DRUG

Sofosbuvir

Exposure of interest for participants who received sofosbuvir in a previous Gilead study for chronic HCV infection.

DRUG

Ribavirin

DRUG

LDV/SOF

Exposure of interest for participants who received LDV/SOF in a previous Gilead study for chronic HCV infection.

DRUG

SOF/VEL

Exposure of interest for participants who received SOF/VEL in a previous Gilead study for chronic HCV infection.

DRUG

SOF/VEL/VOX

Exposure of interest for participants who received SOF/VEL/VOX in a previous Gilead study for chronic HCV infection.

DRUG

Other SOF-Based Regimen

"The other SOF-based regimens may have included the following:~* BMS-790052 (Daclatasvir) + GS-7977 (SOF) with or without RBV~* LDV/SOF + GS-9669, GS-7977 (SOF) + with or without RBV + TMC-435 (Simeprevir)~* LDV/SOF + Vedroprevir (VDV), LDV/SOF + GS-9669 (250 mg and 500 mg)~* LDV/SOF + VDV + RBV~* Simeprevir + SOF~* TMC-435 (Simeprevir) + VEL/SOF"

OTHER

Ineligible parent treatment

Participants were enrolled from ineligible parent treatment group.

Trial Locations (138)

3084

Austin Health, Heidelberg

20251

Universitätsklinikum Hamburg-Eppendorf, Hamburg

Unknown

University of Alabama at Birmingham, Birmingham

Scripps Clinic Medical Group, La Jolla

V.A. Long Beach Medical Center, Long Beach

Cedars Sinai Medical Center, Los Angeles

Kaiser Permanente Medical Center, Los Angeles

Tarrant County ID Associates, Los Angeles

The Liver Center, Pasadena

Inland Empire Liver Foundation, Rialto

University of California, Davis Medical Center, Sacramento

Kaiser Permanente, San Diego

Medical Associates Research Group, San Diego

Quest Clinical Research, San Francisco

University of California at San Francisco Medical Center, San Francisco

Stanford University, Stanford

University of Colorado, Aurora

Georgetown University Medical Center, Washington D.C.

Whitman-Walker Health, Washington D.C.

UF Hepatology Research at CTRB, Gainesville

Borland-Groover Clinic, Jacksonville

University of Miami Miller School of Medicine, Miami

Orlando Immunology Center, Orlando

Tampa General Hospital, Tampa

South Florida Center of Gastroenterology, Wellington

Atlanta Gastroenterology Associates, Atlanta

Atlanta Medical Center, Atlanta

Emory University Hospital Midtown, Atlanta

Gastrointestinal Specialists of Georgia, PC, Marietta

Northwestern University, Chicago

Indiana University, Indianapolis

Indianapolis Gastroenterology Research Foundation, Indianapolis

University of Kansas Medical Center Research Institute, Inc., Kansas City

Delta Research Partners, Monroe

Ochsner Clinic Foundation, New Orleans

Mercy Medical Center, Baltimore

Digestive Disease Associates, PA, Catonsville

Johns Hopkins Hospital/University, Lutherville

University of Michigan Medical Center, Ann Arbor

Henry Ford Health System, Detroit

University of Minnesota Medical Center, Minneapolis

Mayo Clinic, Rochester

Minnesota Gastroenterology, PA, Saint Paul

Kansas City Research Institute, LLC, Kansas City

Saint Louis University, St Louis

Southwest CARE Center, Santa Fe

Binghamton Gastroenterology Associates, PC, Binghamton

North Shore Health Inc., Manhasset

Columbia University Medical Center, New York

Icahn School of Medicine at Mount Sinai, New York

New York University Medical Center, New York

Weill Cornell Medical College, New York

Asheville Gastroenterology Associates, PA, Asheville

Carolinas Medical Center, Charlotte

Duke University Medical Center, Durham

Cumberland Research Associates, LLC, Fayetteville

Cleveland Clinic Foundation, Cleveland

Thomas Jefferson University Hospital, Philadelphia

University of Pennsylvania Health System, Philadelphia

University of Pittsburgh Medical Center, Philadelphia

University of Pittsburgh Medical Center, Pittsburgh

Gastroenterology Center of the MidSouth, P.C., Germantown

Nashville Gastrointestinal Specialists, Inc., Nashville

Vanderbilt University Medical Center, Nashville

The North Texas Clinical Research Institute, Arlington

Baylor Endocrine Center, Dallas

North Texas Research Institute, Dallas

St. Luke's Episcopal Hospital, Houston

The Texas Liver Institute, San Antonio

Intermountain Medical Center, Murray

INOVA Fairfax Hospital, Annandale

Bon Secours St. Mary's Hospital of Richmond, Newport News

Digestive and Liver Disease Specialists, Norfolk

Harborview Medical Center, Seattle

Virginia Mason Medical Center, Seattle

Royal Prince Alfred Hospital, Camperdown

Kirby Institute, Sydney

Westmead Hospital, Westmead

Royal Brisbane & Women's Hospital, Herston

Princess Alexandra Hospital, Woolloongabba

St Vincents Hospital Sydney, Fitzroy

Monash Medical Centre Clayton Campus, Melbourne

The Alfred Hospital, Prahran

Fiona Stanley Hospital, Fremantle

Royal Perth Hospital, Perth

University of Calgary, Calgary

GI Research Institute, Vancouver

Vancouver Infectious Disease Research and Care Centre, Vancouver

London Health Sciences Centre - University Campus, London

University Health Network, Toronto

CRCHUM, Montreal

Hôpital Pontchaillou, Rennes

CHU Montpellier - Hopital St. Eloi, Montpellier

Hôpital Universitaire Dupuytren, Limoges

Hopital Purpan, Toulouse

Hopital Saint Joseph, Marseille

Hopital Haut Leveque, Bordeaux

CHU Estaing, Clermont-Ferrand

Hôpital Beaujon, Clichy

Hopital Henri Mondor, Créteil

CHU de Grenoble- Hopital Michallon, Grenoble

Hopital Cochin, Paris

Hopital Tenon, Paris

Hôpital de la Croix Rousse, Paris

Hôpitaux Universitaires de Strasbourg, Strasbourg

CHU de Nancy-Hopital Brabois Adulte, Vandœuvre-lès-Nancy

Hôpital Paul Brousse, Villejuif

Hopital de La Pitié-Salpêtrière, Paris

Universitatsklinikum Koln, Cologne

Klinikum der Johann Wolfgang Goethe Universitat, Frankfurt am Main

Asklepios Klinik St. Georg, Hamburg

Technische Universität München, Mücheln

Azienda Ospedaliera Ospedale Niguarda Cà Granda, Milan

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

Ospedale Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino

Auckland Clinical Studies Ltd, Auckland

Waikato Hospital, Hamilton

Christchurch Hospital, Christchurch

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

Hospital Virgen de Valme, Seville

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

Barts Health NHS Trust, London

Kings College Hospital, London

St Georges University of London, London

North Manchester General Hospital, Manchester

Nottingham University Hospitals NHS Trust, Nottingham

Gartnavel General Hospital, Glasgow

Queen Alexandra Hospital, Portsmouth

02129

Community Research Initiative of New England, Boston

02215

BIDMC Liver Center, Boston

08844

ID Care, Inc, Hillsborough

02905

University Gastroenterology, Providence

T6G 2B7

University of Alberta, Edmonton

06202

Groupe Hospitalier Archet I Et II, Nice

00927

Fundacion de Investigation de Diego, San Juan

08028

Hospital Clinic de Barcelona, Barcelona

08035

Hospital Universitario Vall d'Hebron, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY