AzTrials
AzTrials

Hepatitis C, ChronicNCT01457768

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

An observational study of Hepatitis C, Chronic, run by Gilead Sciences at 323 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
How many people
570 participants
Where
323 sitesin 16 countries
Study dates
19 Dec 2011to 9 Apr 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

323 sites in 16 countries.

323 sites in 16 countries

United States158 sites

  • University of New Mexico

    Albuquerque, New Mexico

  • Lehigh Valley Health Network, Network Office of Research and Innovation

    Allentown, Pennsylvania, 18102

  • Lehigh Valley Health Network

    Allentown, Pennsylvania

  • Advanced Clinical Research Institute, LLC

    Anaheim, California, 92801

  • The North Texas Research Institute

    Arlington, Texas, 76012

  • Texas Clinical Research Institute, LLC

    Arlington, Texas

  • Asheville Gastroenterology Associates, P.A.

    Asheville, North Carolina, 28801

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30308

  • Emory University

    Atlanta, Georgia, 30308

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • University of Colorado

    Aurora, Colorado, 80045

  • Austin Hospital

    Austin, Texas, 78704

  • Central Texas Clinical Research, LLC

    Austin, Texas

  • Franco Felizarta, MD

    Bakersfield, California, 93301

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Digestive Disease Associates, PA

    Baltimore, Maryland, 21229

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Medical Development Centers, LLC

    Baton Rouge, Louisiana, 70808

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 70809

  • Birmingham Gastroenterology Associates

    Birmingham, Alabama, 35209

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Community Research Initiative of New England

    Boston, Massachusetts

  • Graves-Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases

    Bradenton, Florida, 34209

  • Lahey Clinic Medical Center

    Burlington, Massachusetts, 01805

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • University of Chicago

    Chicago, Illinois, 60637

  • Medical College of Wisconsin

    Chicago, Illinois

  • Northwestern Memorial Hospital

    Chicago, Illinois

  • Southern California Medical Group

    Coronado, California, 92118

  • West Coast Clinical Trials, LLC

    Costa Mesa, California, 92626

  • Nicholaos C. Bellos

    Dallas, Texas, 75204

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Methodist Transplant Physicians

    Dallas, Texas

  • UC Davis Medical Center

    Davis, California, 95616

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Digestive Health Specialists

    Dothan, Alabama, 36305

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • South Denver Gastroenterology

    Englewood, Colorado, 80113

  • Metropolitan Research

    Fairfax, Virginia, 22031

  • Inova Fairfax Hospital Center for Liver Diseases

    Falls Church, Virginia, 22042

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina, 28304

  • University of Florida

    Gainesville, Florida, 32610

  • Gastroenterology Center of the MidSouth, P.C.

    Germantown, Tennessee, 38138

  • Memphis Gastroenterology Group

    Germantown, Tennessee, 38138

  • Gastro One

    Germantown, Tennessee

  • ID Care, Inc.

    Hillsborough, New Jersey, 08844

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Kelsey Research Foundation

    Houston, Texas, 77005

  • Research Specialists of Texas

    Houston, Texas, 77030

  • St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • Baylor College of Medicine

    Houston, Texas

  • St. Luke's Health Baylor College of Medicine Medical Center

    Houston, Texas

  • Indianapolis Gastroenterology Research Foundation

    Indianapolis, Indiana, 46237

  • Indiana University School of Medicine

    Indianapolis, Indiana

  • Binghamton Gastroenterology Associates

    Johnson City, New York, 13790

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160

  • University of Kansas Medical Center

    Kansas City, Kansas

  • Kansas City Gastroenterology and Hepatology

    Kansas City, Missouri, 64131

  • Kaiser Permanente Institute for Health Research

    La Jolla, California, 92037

  • Scripps Clinic

    La Jolla, California, 92037

  • University of California San Diego

    La Jolla, California, 92161

  • eStudySite

    La Mesa, California, 91942

  • Regional Gastroenterology Associates of Lancaster, Ltd.

    Lancaster, Pennsylvania, 17604

  • Impact Clinical Trials

    Las Vegas, Nevada, 89106

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • Kaiser Permanente of Colorado

    Los Angeles, California, 90027

  • Peter J. Ruane, MD, Inc.

    Los Angeles, California, 90036

  • 8631 West 3rd Street

    Los Angeles, California, 90048

  • California Liver Institute

    Los Angeles, California, 90048

  • Anthony Mills MD, Inc

    Los Angeles, California

  • Cedars-Sinai Medical Center

    Los Angeles, California

  • Veterans Administration Wadsworth Medical Center

    Los Angeles, California

  • Wisconsin Hospital and Clinic

    Madison, Wisconsin, 53792

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • Schleinitz Research and Gastroenterology LLC

    Medford, Oregon, 97504

  • University of Miami Miller School of Medicine

    Miami, Florida

  • Research Center at Affiliates in Gastroenterology

    Morristown, New Jersey, 07960

  • Nashville Medical Research Institute

    Nashville, Tennessee, 37205

  • Nashville Gastrointestinal Specialists, Inc

    Nashville, Tennessee, 37211

  • Quality Medical Research, PLLC

    Nashville, Tennessee

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Advanced Research Institute

    New Port Richey, Florida, 34653

  • Concorde Medical Group PLLC

    New York, New York, 10016

  • Weill Medical College of Cornell Univeristy

    New York, New York, 10021

  • St. Luke's Roosevelt Hospital

    New York, New York, 10025

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Mount Sinai Beth Israel

    New York, New York

  • Saint Luke's-Roosevelt Hospital Center

    New York, New York

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Saint Michael's Medical Center

    Newark, New Jersey

  • Liver Institute of Virginia

    Newport News, Virginia

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • eStudySite

    Oceanside, California, 92056

  • Orlando Immunology Center-

    Orlando, Florida, 32803

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • Orlando Clinical Research Center

    Orlando, Florida, 32809

  • Stanford University

    Palo Alto, California, 94304

  • 660 South Fair Oaks Avenue

    Pasadena, California, 91105

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania, 19107

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania

  • University of Pennsylvania School of Medicine

    Philadelphia, Pennsylvania

  • Mayo Clinic

    Phoenix, Arizona

  • UPMC Center For Liver Diseases

    Pittsburgh, Pennsylvania, 15213

  • Veterans Affairs Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania

  • Minnesota Gastroenterology, P.A.

    Plymouth, Minnesota, 55446

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • The Miriam Hospital

    Providence, Rhode Island, 02904

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Liver Institute of Virginia, Bon Secours Health System

    Richmond, Virginia, 23249

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia

  • 200 1st st SW

    Rochester, Minnesota, 55902

  • Mayo Clinic

    Rochester, Minnesota

  • University of Rochester

    Rochester, New York

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Minnesota Gastroenterology, P.A.

    Saint Paul, Minnesota, 55114

  • Lifetree Clinical Research

    Salt Lake City, Utah, 84106

  • University of Utah Pediatric Pulmonology

    Salt Lake City, Utah, 84143

  • PRA Health Sciences

    Salt Lake City, Utah

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • The Texas Liver Institute

    San Antonio, Texas

  • University of California San Diego

    San Diego, California, 92103

  • Research and Education, Inc.

    San Diego, California, 92115

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Quest Clinical Research

    San Francisco, California, 94115

  • University of California, San Francisco School of Medicine

    San Francisco, California, 94143

  • San Francisco General Hospital

    San Francisco, California

  • University of California San Francisco

    San Francisco, California

  • San Jose Gastroenterology

    San Jose, California, 95116

  • Silicon Valley Research Institute

    San Jose, California

  • Southwest C.A.R.E. Center

    Santa Fe, New Mexico, 87505

  • Harborview Medical Center

    Seattle, Washington

  • The Research Institute

    Springfield, Massachusetts, 01105

  • Saint Louis University

    St Louis, Missouri

  • Washington University School of Medicine

    St Louis, Missouri

  • St. Joseph's Comprehensive Research Institute

    Tampa, Florida, 33614

  • Saint Joseph's Hospital

    Tampa, Florida

  • Tampa General Hospital

    Tampa, Florida

  • Los Angeles BioMedical Institute at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    Torrance, California

  • University of Arizona

    Tucson, Arizona, 85724

  • Options Health Research LLC

    Tulsa, Oklahoma, 74104

  • Digestive Health Specialists

    Tupelo, Mississippi, 38801

  • The Gastroenterology Group of South Jersey

    Vineland, New Jersey, 08360

  • Whitman Walker Clinic

    Washington D.C., District of Columbia, 20009

  • Capital Medical Associates, P.C.

    Washington D.C., District of Columbia, 20036

  • South Florida Center of Gastroenterology, P.A.

    Wellington, Florida, 33414

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina, 27103

  • Partners in Internal Medicine, PC

    Worcester, Massachusetts, 01608

  • Westchester Medical Center

    Yonkers, New York, 10701

Other trials in United States

Germany33 sites

  • Leber- and Studienzentrum am Checkpoint

    Berlin, 10969

  • Charite Campus Virchow-Klinikum

    Berlin, 13353

  • Seestrasse 13

    Berlin, 13353

  • MIB Dienstleistung GmbH

    Berlin

  • Universitätsklinikum Bonn

    Bonn, 53105

  • Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum

    Cologne, North Rhine-Westphalia, 50937

  • Medizinisches Versorgungszentrum

    Düsseldorf, North Rhine-Westphalia

  • Universitätsklinikum Düsseldorf

    Düsseldorf, North Rhine-Westphalia

  • Center for HIV and Hepatogastroenterology

    Düsseldorf, 40237

  • Medizinisches Zentrum - Klinik für Gastroenterologie und Hepatologie

    Essen, North Rhine-Westphalia, 45122

  • Klinikum der Johann Wolfgang Goethe Universitaet

    Frankfurt, 60590

  • Klinikum der Johann Wolfgang-Goethe-Universität

    Frankfurt

  • Universitätsklinikum Frankfurt

    Frankfurt

  • Infektiologikum

    Frankfurt am Main, Hesse

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hesse

  • Bertoldstrasse 48

    Freiburg im Breisgau, Baden-Wurttemberg, 79098

  • Albert-Ludwigs-Universität

    Freiburg im Breisgau, Baden-Wurttemberg

  • Medizinische Universitatsklinik

    Freiburg im Breisgau, 79106

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Institut für interdisziplinäre Medizin Studien GmbH an der Asklepiosklinik Saint Georg

    Hamburg

  • CRC Hannover

    Hanover, Lower Saxony

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankhen

    Heidelberg, Baden-Wurttemberg

  • Klinikum der Universität Heidelberg

    Heidelberg, 69120

  • Gastroenterologische Gemeinschaftspraxis

    Herne, North Rhine-Westphalia

  • Gastroenterologische Gemeinschaftspraxis Kiel

    Kiel, 24146

  • University of Leipzig

    Leipzig, 04103

  • Johannes Gutenberg University Hospital

    Mainz, 55131

  • Mainz University

    Mainz

  • Klinikum Innenstadt der LMU Munchen

    München, 81377

  • Universitätsklinik Würzburg

    Wüerzburg

  • Universitätsklinikum Würzburg - Med Klinik und Poliklinik

    Würzburg, 97080

Other trials in Germany

France20 sites

  • Centre Hospitalier Universitaire de Grenoble

    Cedex 9, Auvergne-Rhône-Alpes, 38043

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand, Auvergne

  • Hopital Beaujon

    Clichy, 92110

  • Hôpital Henri Mondor

    Créteil, Île-de-France Region

  • Service des Maladies de l'Appareil Digestif et de la nutrition

    Lille, Hauts-de-France, 59037

  • Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie

    Lille, Hauts-de-France

  • Hôpital-Saint Joseph, Service D'Hépato-Gastroentérologie

    Marseille, Provence-Alpes-Côte d'Azur Region

  • Hopital Saint-Eloi

    Montpellier, 34295

  • Hôpital de I´Archet 2

    Nice, Provence-Alpes-Côte d'Azur Region

  • CHU de Nice - Hôpital l'Archet

    Nice, 06202

  • Hôpital Saint Louis, Services des Maladies Infectieuses

    Paris, 75010

  • Hopital Pitie-Salpetriere

    Paris, 75013

  • Service Maladies Infectieuses

    Paris, Île-de-France Region, 75012

  • Hôpital La Pitié Salpétrière, Service des Maladies Infectieuses

    Paris, Île-de-France Region, 75651

  • Hôpital Bichat-Claude Bernard

    Paris, Île-de-France Region, 75877

  • Hôpital Saint-Antoine

    Paris, Île-de-France Region

  • Hôpital Haut-Lévêque, CHU Bordeaux

    Pessac, Aquitaine

  • Hopital Pontchaillou

    Rennes, 35033

  • C.H.U. Strasbourg - Hôpital Hautpierre - Hématologie

    Strasbourg, 67091

  • CHU de Nancy

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Australia19 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Canberra Specialist Centre

    Canberra, Australian Capital Territory

  • 102 Burton Street

    Darlinghurst, New South Wales, 2010

  • East Sydney Doctors

    Darlinghurst, New South Wales

  • St Vincent's Public Hospital Sydney

    Darlinghurst, New South Wales

  • St Vincent's University Hospital

    Fitzroy, 3065

  • Footscray Hospital

    Footscray, Victoria

  • Austin Health

    Heidelberg, Victoria

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Alfred Hospital - Infectious Disease Unit

    Melbourne, Victoria, 3004

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Monash Medical Centre

    Melbourne, Victoria, 3168

  • Fiona Stanley Hospital

    Murdoch, Western Australia

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Royal Brisbane & Women's Hospital

    QLD, 4029

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Greenslopes Private Hospital

    Woolloongabba, Queensland, 4102

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Italy16 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24128

  • Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera S. Orsola - Malpighi

    Bologna

  • Ente Ospedaliero Ospedali Galliera di Genova

    Genova

  • Ospedale San Raffaele-IRCCS, Centro San Luigi - San Raffaele Turro, Unità Operativa di Malattie Infettive

    Milan, 20127

  • Azienda Ospedaliera

    Milan, 20157

  • Dipartimento Polispecialistico - Malattie Infetive

    Milan, 20162

  • Azienda Ospedaliera Ospedale Niguarda Ca' Granda

    Milan

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan

  • Azienda Ospedaliera Padova, U.O.C. Cardiologia

    Padova

  • Azienda Ospedaliera-universitaria Policlinico P. Giaccone

    Palermo, 90127

  • Azienda Ospedaliero Universitaria di Parma

    Parma

  • Malattie Infettive - Epatologia

    Roma, 00149

  • Fondazione Policlinico Tor Vergata

    Roma

  • Casa Sollievo della Sofferenza Hospital

    San Giovanni Rotondo, Foggia, 71013

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino

Other trials in Italy

Spain14 sites

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08036

  • Hospital Clinic I Provincial de Barcelona

    Barcelona

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Moncloa, Servicio de Enfermedades Infecciosas

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Paseo de la Castellana nº 261

    Madrid, 28046

  • Hospital Universitario La Paz

    Madrid

  • C / Manuel de Falla

    Majadahonda, Madrid, 28222

  • Hospital Puerta de Hierro Majadahonda

    Majadahonda, Madrid

  • Hospital Universitario Nuestra Señora de Valme

    Seville, 41014

  • Hospital Universitario Nuestra Señora de Valme

    Seville

  • Avenida Tres Cruces s/n

    Valencia, 46018

  • Hospital General Universitario de Valencia

    Valencia

Other trials in Spain

United Kingdom13 sites

  • University of Birmingham and Queen Elizabeth Hospital Birmingham

    Birmingham, England

  • Marlborough Street

    Bristol, BS2 8HW

  • Southampton University Hospitals NHS Trust, Southampton General Hospital

    Hampshire, England

  • Westminster Bridge Road

    London, England, SE1 7EH

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, England

  • Guy's and Saint Thomas NHS Foundation Trust

    London, England

  • Imperial College Healthcare NHS Trust

    London, England

  • King's College Hospital

    London, England

  • St George Hospital

    London, England

  • North Manchester General Hospital

    Manchester, England

  • Queen's Medical Centre Campus

    Nottingham, England, NG7 2UH

  • John Radcliffe Hospital

    Oxford, England

  • Derriford Hospital

    Plymouth, PL6 8DH

Other trials in United Kingdom

Canada12 sites

  • University of Calgary

    Calgary, T2N 4Z6

  • University of Alberta

    Edmonton, T6G2C8

  • Hopital Saint-Luc du CHUM

    Montreal, H1T 2M4

  • Inspiration Research Limited

    Toronto, Ontario

  • Toronto General Hospital

    Toronto, M5G 2N2

  • Toronto Western Hospital

    Toronto, M5T 2S8

  • Vancouver Infectious Disease Research and Care Centre

    Vancouver, British Columbia

  • LAIR Centre

    Vancouver, V5Z 1H2

  • Gordon & Leslie Diamond Health Care Centre

    Vancouver, V5Z 1M9

  • University of British Colombia

    Vancouver, V6Z 2C9

  • GIRI GI Research Institute

    Vancouver, V6Z 2K5

  • University of Manitoba, Health Sciences Center

    Winnipeg, R3E 3P4

Other trials in Canada

Poland10 sites

  • Wojewódzki Szpital Specjalistyczny im. Kazimierza Dluskiego w Bialymstoku

    Bialystok, Podlaskie Voivodeship

  • Szpital Specjalistyczny w Chorzowie

    Chorzów, Silesian Voivodeship

  • SP ZOZ Wojewodzki Szpital Zakazny w Warszawie

    Chorzów, 41-500

  • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

    Lodz, 91-347

  • ID Clinic

    Mysłowice, Silesian Voivodeship

  • NZOZ Pol-SaNa-Med

    Mysłowice, 41-400

  • Oddzial Dzienny

    Warsaw, Masovian Voivodeship, 01-201

  • SP ZOZ Wojewódzki Szpital Zakazny

    Warsaw, Masovian Voivodeship

  • Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy

    Wroclaw, Lower Silesian Voivodeship

  • NZOZ Centrum Badan Klinicznych

    Wroclaw, Lower Silesian Voivodeship

Other trials in Poland

New Zealand9 sites

  • Christchurch Hospital

    Christchurch, 8011

  • Auckland Clinical Studies Limited

    Grafton, Auckland, 1010

  • Middlemore Hospital

    Grafton, Auckland, 1010

  • Auckland City Hospital

    Grafton, Auckland

  • Waikato Hospital (District Health Board)

    Hamilton, 2001

  • Urosurgery

    Hamilton

  • Wellington Hospital

    Newton, WGN, 6021

  • Bay of Plenty Clinical School

    Tauranga, Bay of Plenty

  • Wellington Hospital

    Wellington

Other trials in New Zealand

Sweden6 sites

  • Sahlgrenska Universitetssjukhuset, Östra sjukhuset

    Gothenburg, Västra Götaland County

  • Sahlgrenska Universitetssjukhuset, Östra Sjukhus

    Gothenburg, 41685

  • Skånes Universitetssjukhus

    Lund, 22185

  • Skånes Universitetssjukhus i Lund

    Lund

  • Skånes Universitetssjukhus, Malmö

    Malmö

  • Karolinska Universitetssjukhuset Solna

    Solna, 17176

Other trials in Sweden

Netherlands4 sites

  • Academisch Medisch Centrum

    Amsterdam, North Holland

  • Leiden Universitair Medisch Centrum

    Leiden, South Holland

  • Universitair Medisch Centrum Sint Radboud

    Nijmegen

  • Erasmus Medisch Centrum

    Rotterdam, South Holland

Other trials in Netherlands

Puerto Rico3 sites

  • Chattanooga Hem/Oncology Ass (SCRI)

    San Juan, PR, 00909

  • Clinical Research Puerto Rico

    San Juan, PR

  • Fundacion De Investigacion De Diego

    San Juan, 927

Other trials in Puerto Rico

Austria2 sites

  • Medizinische Universität Graz

    Graz, Styria

  • Wilhelminenspital der Stadt Wien

    Vienna, State of Vienna

Other trials in Austria

Czechia2 sites

  • Klinmed, s.r.o.

    Prague, 16902

  • Remedis, s.r.o., Nestátní zdravotnické zarízení, Vladimírova 10

    Prague

Other trials in Czechia

Estonia2 sites

  • West Tallinn Central Hospital

    Talinn

  • Tartu University Hospital

    Tartu

Other trials in Estonia

About this study

Official title: 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.

Keywords
Hepatitis C, HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Tegobuvir, Registry, HCV RNA, Treatment experienced, Treatment naive, GS 9451, GS 5885, Sequence, GS 5816, GS 7977, Sofosbuvir, Sovaldi™, SOF, Ledipasvir, LDV
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimen

    Measured: Up to 3 years

Secondary outcomes (4)

  1. Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen

    Measured: Up to 3 years

  2. Average number of DRM loss by treatment regimen

    Measured: Up to 3 years

  3. Liver disease progression

    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.

    Measured: Up to 3 years

  4. Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen

    Measured: Up to 144 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2011 (estimated)
  2. Study start19 Dec 2011
  3. Primary completion9 Apr 2018
  4. Study completion9 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
570 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01457768
Sponsor's protocol ID
GS-US-248-0123
Other IDs
2011-000946-39
Status last verified
May 2018
First submitted
4 Oct 2011
Last updated
4 May 2018
Results posted
No
Data monitoring committee
No

Publications

  • Younossi ZM, Stepanova M, Racila A, Afendy A, Lawitz EJ, Schwabe C, Ruane PJ, Lalezari J, Reddy KR, Jacobson IM, Muir AJ, Gaggar A, Myers RP, Younossi I, Nader F. Long-term Benefits of Sustained Virologic Response for Patient-Reported Outcomes in Patients With Chronic Hepatitis C Virus Infection. Clin Gastroenterol Hepatol. 2020 Feb;18(2):468-476.e11. doi: 10.1016/j.cgh.2019.07.047. Epub 2019 Jul 31.

    PubMed 31376493

  • Younossi ZM, Stepanova M, Jacobson I, Muir AJ, Pol S, Zeuzem S, Younes Z, Herring R, Lawitz E, Younossi I, Racila A. Not Achieving Sustained Viral Eradication of Hepatitis C Virus After Treatment Leads to Worsening Patient-reported Outcomes. Clin Infect Dis. 2020 Feb 3;70(4):628-632. doi: 10.1093/cid/ciz243.

    PubMed 30949674

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, Chronic, run by Gilead Sciences at 323 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 323 sites in United States, Germany, France, Australia, Italy and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01457768, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.

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