A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response

May 3, 2018 updated by: Gilead Sciences

A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection

This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

570

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Fitzroy, Australia, 3065
        • St Vincent's University Hospital
      • QLD, Australia, 4029
        • Royal Brisbane & Women's Hospital
      • Woolloongabba, Australia, 4102
        • Princess Alexandra Hospital
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia
        • Canberra Specialist Centre
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • 102 Burton Street
      • Darlinghurst, New South Wales, Australia
        • East Sydney Doctors
      • Darlinghurst, New South Wales, Australia
        • St Vincent's Public Hospital Sydney
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Greenslopes Private Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Footscray, Victoria, Australia
        • Footscray Hospital
      • Heidelberg, Victoria, Australia
        • Austin Health
      • Melbourne, Victoria, Australia, 3168
        • Monash Medical Centre
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital - Infectious Disease Unit
    • Western Australia
      • Murdoch, Western Australia, Australia
        • Fiona Stanley Hospital
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Austria
    • Styria
      • Graz, Styria, Austria
        • Medizinische Universität Graz
    • Vienna
      • Wien, Vienna, Austria
        • Wilhelminenspital der Stadt Wien
  • Canada
      • Calgary, Canada, T2N 4Z6
        • University of Calgary
      • Edmonton, Canada, T6G2C8
        • University of Alberta
      • Montreal, Canada, H1T 2M4
        • Hopital Saint-Luc du CHUM
      • Toronto, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Canada, M5G 2N2
        • Toronto General Hospital
      • Vancouver, Canada, V5Z 1H2
        • Lair Centre
      • Vancouver, Canada, V5Z 1M9
        • Gordon & Leslie Diamond Health Care Centre
      • Vancouver, Canada, V6Z 2C9
        • University of British Colombia
      • Vancouver, Canada, V6Z 2K5
        • GIRI GI Research Institute
      • Winnipeg, Canada, R3E 3P4
        • University of Manitoba, Health Sciences Center
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver Infectious Disease Research and Care Centre
    • Ontario
      • Toronto, Ontario, Canada
        • Inspiration Research Limited
  • Czechia
      • Praha 4, Czechia
        • Remedis, s.r.o., Nestátní zdravotnické zarízení, Vladimírova 10
      • Praha 6, Czechia, 16902
        • Klinmed, s.r.o.
  • Estonia
      • Talinn, Estonia
        • West Tallinn Central Hospital
      • Tartu, Estonia
        • Tartu University Hospital
  • France
      • Montpellier, France, 34295
        • Hopital Saint-Eloi
      • Nice cedex 3, France, 06202
        • CHU DE Nice - Hôpital l'Archet
      • Paris, France, 75013
        • Hopital Pitie-Salpetriere
      • Paris, France, 75010
        • Hôpital Saint Louis, Services des Maladies Infectieuses
      • Rennes Cedex 9, France, 35033
        • Hopital Pontchaillou
      • Strasbourg, France, 67091
        • C.H.U. Strasbourg - Hôpital Hautpierre - Hématologie
      • Vandoeuvre, France, 54500
        • CHU de NANCY
      • clichy Cedex, France, 92110
        • Hôpital Beaujon
    • Aquitaine
      • Pessac Cedex, Aquitaine, France
        • Hôpital Haut-Lévêque, CHU Bordeaux
    • Auvergne
      • Clermont-Ferrand, Auvergne, France
        • Centre Hospitalier Universitaire de Clermont-Ferrand
    • Ile-de-france
      • CRETEIL Cedex, Ile-de-france, France
        • Hôpital Henri Mondor
      • Paris, Ile-de-france, France, 75651
        • Hôpital La Pitié Salpétrière, Service des Maladies Infectieuses
      • Paris Cedex 12, Ile-de-france, France, 75012
        • Service Maladies Infectieuses
      • Paris cedex 12, Ile-de-france, France
        • Hôpital Saint-Antoine
      • Paris cedex 18, Ile-de-france, France, 75877
        • Hopital Bichat-Claude Bernard
    • NORD Pas-de-calais
      • Lille, NORD Pas-de-calais, France, 59037
        • Service des Maladies de l'Appareil Digestif et de la nutrition
      • Lille, NORD Pas-de-calais, France
        • Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie
    • Provence Alpes COTE D'azur
      • Marseille cedex 08, Provence Alpes COTE D'azur, France
        • Hôpital-Saint Joseph, Service D'Hépato-Gastroentérologie
      • Nice, Provence Alpes COTE D'azur, France
        • Hôpital de I´Archet 2
    • Rhone-alpes
      • Cedex 9, Rhone-alpes, France, 38043
        • Centre Hospitalier Universitaire de Grenoble
  • Germany
      • Berlin, Germany, 13353
        • Charité Campus Virchow-Klinikum
      • Berlin, Germany, 10969
        • Leber- and Studienzentrum am Checkpoint
      • Berlin, Germany, 13353
        • Seestrasse 13
      • Berlin, Germany
        • MIB Dienstleistung GmbH
      • Bonn, Germany, 53105
        • Universitatsklinikum Bonn
      • Dusseldorf, Germany, 40237
        • Center for HIV and Hepatogastroenterology
      • Frankfurt, Germany, 60590
        • Klinikum der Johann Wolfgang Goethe Universitaet
      • Frankfurt, Germany
        • Universitätsklinikum Frankfurt
      • Frankfurt, Germany
        • Klinikum der Johann Wolfgang-Goethe-Universität
      • Freiburg, Germany, 79106
        • Medizinische Universitätsklinik
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
      • Hamburg, Germany
        • Institut für interdisziplinäre Medizin Studien GmbH an der Asklepiosklinik Saint Georg
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69120
        • Klinikum der Universität Heidelberg
      • Kiel, Germany, 24146
        • Gastroenterologische Gemeinschaftspraxis Kiel
      • Leipzig, Germany, 04103
        • University of Leipzig
      • Mainz, Germany
        • Mainz University
      • Mainz, Germany, 55131
        • Johannes Gutenberg University Hospital
      • Muenchen, Germany, 81377
        • Klinikum Innenstadt der LMU Munchen
      • Wurzburg, Germany, 97080
        • Universitätsklinikum Würzburg - Med Klinik und Poliklinik
      • Wüerzburg, Germany
        • Universitätsklinik Würzburg
    • Baden-wuerttemberg
      • Freiburg, Baden-wuerttemberg, Germany
        • Albert-Ludwigs-Universität
      • Freiburg im Breisgau, Baden-wuerttemberg, Germany, 79098
        • Bertoldstrasse 48
      • Heidelberg, Baden-wuerttemberg, Germany
        • Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankhen
    • Hessen
      • Frankfurt am Main, Hessen, Germany
        • Infektiologikum
      • Frankfurt am Main, Hessen, Germany
        • Universitätsklinikum Frankfurt
    • Niedersachsen
      • Hannover, Niedersachsen, Germany
        • CRC Hannover
    • Nordrhein-westfalen
      • Düsseldorf, Nordrhein-westfalen, Germany
        • Medizinisches Versorgungszentrum
      • Düsseldorf, Nordrhein-westfalen, Germany
        • Universitätsklinikum Düsseldorf
      • Essen, Nordrhein-westfalen, Germany, 45122
        • Medizinisches Zentrum - Klinik für Gastroenterologie und Hepatologie
      • Herne, Nordrhein-westfalen, Germany
        • Gastroenterologische Gemeinschaftspraxis
      • Köln, Nordrhein-westfalen, Germany, 50937
        • Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum
  • Italy
      • Bergamo, Italy, 24128
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Bologna, Italy, 40138
        • Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
      • Bologna, Italy
        • Azienda Ospedaliera S. Orsola - Malpighi
      • Genova, Italy
        • Ente Ospedaliero Ospedali Galliera di Genova
      • Milano, Italy
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Milano, Italy, 20127
        • Ospedale San Raffaele-IRCCS, Centro San Luigi - San Raffaele Turro, Unità Operativa di Malattie Infettive
      • Milano, Italy, 20157
        • Azienda Ospedaliera
      • Milano, Italy, 20162
        • Dipartimento Polispecialistico - Malattie Infetive
      • Milano, Italy
        • Azienda Ospedaliera Ospedale Niguarda Ca' Granda
      • Padova, Italy
        • Azienda Ospedaliera Padova, U.O.C. Cardiologia
      • Palermo, Italy, 90127
        • Azienda Ospedaliera-universitaria Policlinico P. Giaccone
      • Parma, Italy
        • Azienda Ospedaliero Universitaria di Parma
      • Roma, Italy, 00149
        • Malattie Infettive - Epatologia
      • Roma, Italy
        • Fondazione Policlinico Tor Vergata
      • Torino, Italy
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Casa Sollievo della Sofferenza Hospital
  • Netherlands
      • Nijmegen, Netherlands
        • Universitair Medisch Centrum Sint Radboud
    • Noord-holland
      • Amsterdam, Noord-holland, Netherlands
        • Academisch Medisch Centrum
    • Zuid-holland
      • Leiden, Zuid-holland, Netherlands
        • Leiden Universitair Medisch Centrum
      • Rotterdam, Zuid-holland, Netherlands
        • Erasmus Medisch Centrum
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
      • Hamilton, New Zealand, 2001
        • Waikato Hospital (District Health Board)
      • Hamilton, New Zealand
        • Urosurgery
      • Wellington, New Zealand
        • Wellington Hospital
    • Auckland
      • Grafton, Auckland, New Zealand
        • Auckland City Hospital
      • Grafton, Auckland, New Zealand, 1010
        • Auckland Clinical Studies Limited
      • Grafton, Auckland, New Zealand, 1010
        • Middlemore Hospital
    • BAY OF Plenty
      • Tauranga, BAY OF Plenty, New Zealand
        • Bay of Plenty Clinical School
    • WGN
      • Newton, WGN, New Zealand, 6021
        • Wellington Hospital
  • Poland
      • Chorzow, Poland, 41-500
        • SP ZOZ Wojewodzki Szpital Zakazny w Warszawie
      • Lodz, Poland, 91-347
        • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
      • Myslowice, Poland, 41-400
        • NZOZ Pol-SaNa-Med
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland
        • Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy
      • Wroclaw, Dolnoslaskie, Poland
        • NZOZ Centrum Badan Klinicznych
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 01-201
        • Oddzial Dzienny
      • Warszawa, Mazowieckie, Poland
        • SP ZOZ Wojewódzki Szpital Zakazny
    • Podlaskie
      • Bialystok, Podlaskie, Poland
        • Wojewodzki Szpital Specjalistyczny im. Kazimierza Dluskiego w Bialymstoku
    • Slaskie
      • Chorzów, Slaskie, Poland
        • Szpital Specjalistyczny w Chorzowie
      • Myslowice, Slaskie, Poland
        • ID Clinic
  • Puerto Rico
      • San Juan, Puerto Rico, 927
        • Fundacion De Investigacion de Diego
      • San Juan, Puerto Rico, 00909
        • Chattanooga Hem/Oncology Ass (SCRI)
      • San Juan, Puerto Rico
        • Clinical Research Puerto Rico
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain
        • Hospital Clinic i Provincial de Barcelona
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain, 28034
        • Hospital Moncloa, Servicio de Enfermedades Infecciosas
      • Madrid, Spain, 28046
        • Paseo de la Castellana nº 261
      • Sevilla, Spain, 41014
        • Hospital Universitario Nuestra Señora de Valme
      • Sevilla, Spain
        • Hospital Universitario Nuestra Señora de Valme
      • Valencia, Spain
        • Hospital General Universitario de Valencia
      • Valencia, Spain, 46018
        • Avenida Tres Cruces s/n
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • C / Manuel de Falla
      • Majadahonda, Madrid, Spain
        • Hospital Puerta de Hierro Majadahonda
  • Sweden
      • Göteborg, Sweden, 41685
        • Sahlgrenska Universitetssjukhuset, Östra Sjukhus
      • Lund, Sweden
        • Skanes Universitetssjukhus I Lund
      • Lund, Sweden, 22185
        • Skanes Universitetssjukhus
      • Malmö, Sweden
        • Skånes Universitetssjukhus, Malmö
      • Solna, Sweden, 17176
        • Karolinska Universitetssjukhuset Solna
    • Vastra Gotaland
      • Göteborg, Vastra Gotaland, Sweden
        • Sahlgrenska Universitetssjukhuset, Östra sjukhuset
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • Marlborough Street
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
    • England
      • Birmingham, England, United Kingdom
        • University of Birmingham and Queen Elizabeth Hospital Birmingham
      • Hampshire, England, United Kingdom
        • Southampton University Hospitals NHS Trust, Southampton General Hospital
      • London, England, United Kingdom, SE1 7EH
        • Westminster Bridge Road
      • London, England, United Kingdom
        • Chelsea and Westminster Hospital NHS Foundation Trust
      • London, England, United Kingdom
        • Guy's and Saint Thomas NHS Foundation Trust
      • London, England, United Kingdom
        • Imperial College Healthcare NHS Trust
      • London, England, United Kingdom
        • King's College Hospital
      • London, England, United Kingdom
        • St George Hospital
      • Manchester, England, United Kingdom
        • North Manchester General Hospital
      • Nottingham, England, United Kingdom, NG7 2UH
        • Queen's Medical Centre Campus
      • Oxford, England, United Kingdom
        • John Radcliffe Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35209
        • Birmingham Gastroenterology Associates
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists
    • Arizona
      • Phoenix, Arizona, United States
        • Mayo Clinic
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute, LLC
      • Bakersfield, California, United States, 93301
        • Franco Felizarta, MD
      • Coronado, California, United States, 92118
        • Southern California Medical Group
      • Costa Mesa, California, United States, 92626
        • West Coast Clinical Trials, Llc
      • Davis, California, United States, 95616
        • UC Davis Medical Center
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • La Jolla, California, United States, 92037
        • Kaiser Permanente Institute for Health Research
      • La Jolla, California, United States, 92161
        • University of California San Diego
      • La Mesa, California, United States, 91942
        • eStudySite
      • Long Beach, California, United States, 90822
        • VA Long Beach Healthcare System
      • Los Angeles, California, United States
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90036
        • Peter J. Ruane, MD, Inc.
      • Los Angeles, California, United States, 90048
        • California Liver Institute
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente of Colorado
      • Los Angeles, California, United States, 90048
        • 8631 West 3rd Street
      • Los Angeles, California, United States
        • Anthony Mills MD, Inc
      • Los Angeles, California, United States
        • Veterans Administration Wadsworth Medical Center
      • Oceanside, California, United States, 92056
        • eStudySite
      • Palo Alto, California, United States, 94304
        • Stanford University
      • Pasadena, California, United States, 91105
        • 660 South Fair Oaks Avenue
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center
      • San Diego, California, United States, 92123
        • Medical Associates Research Group, Inc.
      • San Diego, California, United States, 92103
        • University of California San Diego
      • San Diego, California, United States, 92115
        • Research and Education, Inc.
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
      • San Francisco, California, United States
        • University of California San Francisco
      • San Francisco, California, United States
        • San Francisco General Hospital
      • San Francisco, California, United States, 94143
        • University of California, San Francisco School of Medicine
      • San Jose, California, United States, 95116
        • San Jose Gastroenterology
      • San Jose, California, United States
        • Silicon Valley Research Institute
      • Torrance, California, United States, 90502
        • Los Angeles Biomedical Institute at Harbor-UCLA Medical Center
      • Torrance, California, United States
        • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Englewood, Colorado, United States, 80113
        • South Denver Gastroenterology
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Whitman Walker Clinic
      • Washington, District of Columbia, United States, 20036
        • Capital Medical Associates, P.C.
    • Florida
      • Bradenton, Florida, United States, 34209
        • Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Miami, Florida, United States
        • University of Miami Miller School of Medicine
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center
      • Orlando, Florida, United States, 32806
        • Internal Medicine Specialists
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center-
      • Tampa, Florida, United States
        • Tampa General Hospital
      • Tampa, Florida, United States, 33614
        • St. Joseph's Comprehensive Research Institute
      • Tampa, Florida, United States
        • Saint Joseph's Hospital
      • Wellington, Florida, United States, 33414
        • South Florida Center of Gastroenterology, P.A.
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University
      • Atlanta, Georgia, United States, 30309
        • Digestive Healthcare of Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Gastroenterology Associates
      • Decatur, Georgia, United States, 30033
        • Infectious Disease Specialists of Atlanta
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia, PC
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States
        • Medical College of Wisconsin
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University School of Medicine
      • Indianapolis, Indiana, United States, 46237
        • Indianapolis Gastroenterology Research Foundation
    • Kansas
      • Kansas City, Kansas, United States
        • University of Kansas Medical Center
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center Research Institute, Inc.
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves-Gilbert Clinic
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Gastroenterology Associates, LLC
      • Baton Rouge, Louisiana, United States, 70808
        • Medical Development Centers, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
      • Baltimore, Maryland, United States, 21229
        • Digestive Disease Associates, PA
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States
        • Community Research Initiative of New England
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic Medical Center
      • Springfield, Massachusetts, United States, 01105
        • The Research Institute
      • Worcester, Massachusetts, United States, 01608
        • Partners in Internal Medicine, PC
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Minnesota Gastroenterology, P.A.
      • Rochester, Minnesota, United States
        • Mayo Clinic
      • Rochester, Minnesota, United States, 55902
        • 200 1st st SW
      • Saint Paul, Minnesota, United States, 55114
        • Minnesota Gastroenterology, P.A.
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Digestive Health Specialists
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Gastroenterology and Hepatology
      • Saint Louis, Missouri, United States
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States
        • Saint Louis University
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Impact Clinical Trials
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • ID Care, Inc.
      • Morristown, New Jersey, United States, 07960
        • Research Center at Affiliates in Gastroenterology
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Medical Center
      • Newark, New Jersey, United States
        • Saint Michael's Medical Center
      • Vineland, New Jersey, United States, 08360
        • The Gastroenterology Group of South Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States
        • University of New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Southwest C.A.R.E. Center
    • New York
      • Johnson City, New York, United States, 13790
        • Binghamton Gastroenterology Associates
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10016
        • Concorde Medical Group PLLC
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell Univeristy
      • New York, New York, United States, 10025
        • St. Luke's Roosevelt Hospital
      • New York, New York, United States
        • Mount Sinai Beth Israel
      • New York, New York, United States
        • Saint Luke's-Roosevelt Hospital Center
      • Rochester, New York, United States
        • University of Rochester
      • Yonkers, New York, United States, 10701
        • Westchester Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates, P.A.
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina At Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Associates, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists, PA
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research LLC
    • Oregon
      • Medford, Oregon, United States, 97504
        • Schleinitz Research and Gastroenterology LLC
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18102
        • Lehigh Valley Health Network, Network Office of Research and Innovation
      • Allentown, Pennsylvania, United States
        • Lehigh Valley Health Network
      • Lancaster, Pennsylvania, United States, 17604
        • Regional Gastroenterology Associates of Lancaster, Ltd.
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia FIGHT
      • Philadelphia, Pennsylvania, United States
        • University of Pennsylvania School of medicine
      • Philadelphia, Pennsylvania, United States
        • Philadelphia FIGHT
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Center for Liver Diseases
      • Pittsburgh, Pennsylvania, United States
        • Veterans Affairs Pittsburgh Healthcare System
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology
      • Providence, Rhode Island, United States, 02904
        • The Miriam Hospital
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Memphis Gastroenterology Group
      • Germantown, Tennessee, United States, 38138
        • Gastroenterology Center of the Midsouth, P.C.
      • Germantown, Tennessee, United States
        • Gastro One
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research Institute
      • Nashville, Tennessee, United States
        • Quality Medical Research, PLLC
      • Nashville, Tennessee, United States, 37211
        • Nashville Gastrointestinal Specialists, Inc
    • Texas
      • Arlington, Texas, United States, 76012
        • The North Texas Research Institute
      • Arlington, Texas, United States
        • Texas Clinical Research Institute, LLC
      • Austin, Texas, United States, 78704
        • Austin Hospital
      • Austin, Texas, United States
        • Central Texas Clinical Research, LLC
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center at Dallas
      • Dallas, Texas, United States, 75204
        • Nicholaos C. Bellos
      • Dallas, Texas, United States
        • Methodist Transplant Physicians
      • Houston, Texas, United States, 77005
        • Kelsey Research Foundation
      • Houston, Texas, United States, 77030
        • St. Luke's Episcopal Hospital
      • Houston, Texas, United States
        • Baylor College of Medicine
      • Houston, Texas, United States, 77004
        • Therapeutic Concepts, PA
      • Houston, Texas, United States, 77030
        • Research Specialists of Texas
      • Houston, Texas, United States
        • St. Luke's Health Baylor College of Medicine Medical Center
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research
      • San Antonio, Texas, United States
        • The Texas Liver Institute
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Lifetree Clinical Research
      • Salt Lake City, Utah, United States, 84143
        • University of Utah Pediatric Pulmonology
      • Salt Lake City, Utah, United States
        • PRA Health Sciences
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Metropolitan Research
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital Center for Liver Diseases
      • Newport News, Virginia, United States
        • Liver Institute of Virginia
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
      • Richmond, Virginia, United States
        • Virginia Commonwealth University Medical Center
      • Richmond, Virginia, United States, 23249
        • Liver Institute of Virginia, Bon Secours Health System
    • Washington
      • Seattle, Washington, United States
        • Harborview Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Wisconsin Hospital and Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead OAV in a previous Gilead-sponsored HCV study.

Description

Key Inclusion Criteria:

  • Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead OAV
  • Have failed to achieve an SVR in a previous Gilead-sponsored study, as defined in the original treatment protocol
  • Provide written, informed consent
  • Be willing and able to comply with the visit schedule

Key Exclusion Criteria:

  • Individuals planning to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry
  • History of clinically significant illness or any other major medical disorder that may interfere with follow-up, assessments or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimen
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen
Time Frame: Up to 3 years
Up to 3 years
Average number of DRM loss by treatment regimen
Time Frame: Up to 3 years
Up to 3 years
Liver disease progression
Time Frame: Up to 3 years
Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.
Up to 3 years
Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen
Time Frame: Up to 144 weeks
Up to 144 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2011

Primary Completion (Actual)

April 9, 2018

Study Completion (Actual)

April 9, 2018

Study Registration Dates

First Submitted

October 4, 2011

First Submitted That Met QC Criteria

October 20, 2011

First Posted (Estimate)

October 24, 2011

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-248-0123
  • 2011-000946-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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