AzTrials
AzTrials

Hepatitis C, ChronicNCT01457755

Gilead Sustained Virologic Response (SVR) Registry

An observational study of Hepatitis C, Chronic, run by Gilead Sciences at 325 sites in 17 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 provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV. 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
6,625 participants
Where
325 sitesin 17 countries
Study dates
13 Apr 2012to 8 Jan 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 achieved sustained virologic response (SVR) while participating 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 oral antiviral agent (OAV)
  • Have achieved SVR in a Gilead-sponsored study, as defined in the original treatment protocol
  • Provide written, informed consent
  • Be willing and able to comply with the visit schedule and protocol-mandated procedures

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

325 sites in 17 countries.

325 sites in 17 countries

United States162 sites

  • University of New Mexico

    Albuquerque, New Mexico

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

    Allentown, Pennsylvania, 18102

  • Advanced Clinical Research Institute, LLC

    Anaheim, California, 92801

  • University of Michigan Medical Center

    Ann Arbor, Michigan

  • Metropolitan Research

    Annandale, Virginia

  • The North Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Asheville Gastroenterology Associates, P.A.

    Asheville, North Carolina, 28801

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30308

  • The Emory Clinic

    Atlanta, Georgia, 30308

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • Atlanta Medical Center

    Atlanta, Georgia, 30312

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • 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

  • Delta Research Partners, LLC

    Bastrop, Louisiana, 71220

  • Medical Development Centers, LLC

    Baton Rouge, Louisiana, 70808

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 70809

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • Binghamton Gastroenterology Associates, PC

    Binghamton, New York

  • 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

  • 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 North Carolina

    Chapel Hill, North Carolina

  • Carolinas Medical Center

    Charlotte, North Carolina

  • Ruth M. Rothstein CORE Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Northwestern Memorial Hospital

    Chicago, Illinois

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0595

  • University of Maryland

    College Park, Maryland, 20742

  • University of Miami - Dept of Neurology

    Coral Gables, Florida, 33146

  • Southern California Liver Centers

    Coronado, California, 92118

  • West Coast Clinical Trials, LLC

    Costa Mesa, California, 92626

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

  • Baylor Endocrine Center

    Dallas, Texas, 75246

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Methodist Dallas Medical Center

    Dallas, Texas

  • Southwest Infectious Disease Clinical Research, Inc

    Dallas, Texas

  • Dekalb Gastroenterology Associates, LLC

    Decatur, Georgia, 30033-6134

  • Infectious Disease Specialists of Atlanta, PC

    Decatur, Georgia, 30033

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Digestive Health Specialists of the Southeast, PA

    Dothan, Alabama, 35305

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • South Denver Gastroenterology

    Englewood, Colorado, 80113

  • Inova Fairfax Hospital Center for Liver Diseases

    Falls Church, Virginia, 22042

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina, 28304

  • University of Florida Hepatology Research at CTRB

    Gainesville, Florida, 32610

  • Memphis Gastroenterology Group

    Germantown, Tennessee, 38138

  • Gastro One

    Germantown, Tennessee

  • Gastroenterology Center of Connecticut

    Hamden, Connecticut, 06518

  • ID Care, Inc.

    Hillsborough, New Jersey, 08844

  • The Queen's Medical Center-Liver Center

    Honolulu, Hawaii, 96813

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Kelsey Research Foundation

    Houston, Texas, 77005

  • Research Specialists of Texas

    Houston, Texas, 77030

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

    Houston, Texas, 77030

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Baylor College of Medicine

    Houston, Texas

  • CHI Health Reseach Center

    Houston, Texas

  • Indianapolis Gastroenterology Research Foundation

    Indianapolis, Indiana, 46237

  • Indiana University School of Medicine

    Indianapolis, Indiana

  • Borland-Groover Clinic

    Jacksonville, Florida, 32207

  • University of Kansas Medical Center

    Kansas City, Kansas

  • Kansas City Research Institute, LLC

    Kansas City, Missouri

  • The Kansas City Free Health Clinic

    Kansas City, Missouri

  • Scripps Clinic Medical Group

    La Jolla, California, 92037

  • eStudySite

    La Mesa, California, 91942

  • Regional Gastroenterology Associates of Lancaster, Ltd.

    Lancaster, Pennsylvania, 17604

  • Gastroenterology Consultants PLC

    Live Oak, Texas

  • Long Beach VA Medical Center

    Long Beach, California, 90822

  • Ruane Clinical Research Group

    Los Angeles, California, 90036

  • National Research Institute

    Los Angeles, California, 90057

  • Anthony Mills MD, Inc

    Los Angeles, California

  • Cedars-Sinai Medical Center

    Los Angeles, California

  • Kaiser Permanente

    Los Angeles, California

  • Veterans Administration Wadsworth Medical Center

    Los Angeles, California

  • Johns Hopkins University

    Lutherville, Maryland, 21093

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin

  • Northwell Health

    Manhasset, New York, 11030

  • Northwell Health

    Manhasset, New York

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • Schleinitz Research and Gastroenterology LLC

    Medford, Oregon, 97504

  • University of Miami

    Miami, Florida, 33136

  • Atlantic Research Affiliates, LLC

    Morristown, New Jersey

  • Intermountain Medical Center

    Murray, Utah, 84107

  • The Frist Clinic

    Nashville, Tennessee, 37203

  • Nashville Medical Research Institute

    Nashville, Tennessee, 37205

  • Quality Medical Research, PLLC

    Nashville, Tennessee

  • Yale University

    New Haven, Connecticut, 06520

  • Advanced Research Institute

    New Port Richey, Florida, 34653

  • Concorde Medical Group PLLC

    New York, New York, 10016

  • Weill Cornell Medical College of Cornell Univeristy

    New York, New York, 10021

  • St. Luke's Roosevelt Hospital

    New York, New York, 10025

  • Columbia Presbyterian Hospital, Columbia University

    New York, New York, 10032

  • Icahn School of Medicine at Mount Sinai

    New York, New York

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Liver Institute of Virginia

    Newport News, Virginia

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • eStudySite

    Oceanside, California, 92056

  • Orlando Immunology Center

    Orlando, Florida, 32803-1851

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • Orlando Clinical Research Center

    Orlando, Florida, 32809

  • Stanford University

    Palo Alto, California, 94304

  • Huntington Medical Research Institutes

    Pasadena, California

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania, 19107

  • 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

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • The Miriam Hospital

    Providence, Rhode Island

  • Inland Empire Liver Foundation

    Rialto, California

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia

  • Mayo Clinic

    Rochester, Minnesota

  • University of Rochester

    Rochester, New York

  • University of California Davis Medical Center

    Sacramento, California, 95187

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Minnesota Gastroenterology

    Saint Paul, Minnesota, 55114

  • University of Utah

    Salt Lake City, Utah, 84143

  • PRA Health Sciences

    Salt Lake City, Utah

  • The Texas Liver Institute

    San Antonio, Texas

  • University of California at San Diego

    San Diego, California, 92103

  • Research and Education, Inc.

    San Diego, California, 92115

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • Kaiser Permanente

    San Diego, California, 92154

  • University of California San Diego

    San Diego, California, 92161

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Quest Clinical Research

    San Francisco, California, 94115

  • Kaiser Permanente Center

    San Francisco, California

  • Silicon Valley Research Institute

    San Jose, California

  • Southwest C.A.R.E. Center

    Santa Fe, New Mexico, 87505

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Harborview Medical Center

    Seattle, Washington

  • The Research Institute

    Springfield, Massachusetts, 01105

  • Washington University School of Medicine

    St Louis, Missouri, 63108

  • Saint Louis University

    St Louis, Missouri

  • Carolinas Center for Liver Disease

    Statesville, North Carolina

  • Saint Joseph's Hospital

    Tampa, Florida

  • Tampa General Hospital

    Tampa, Florida

  • Bronx Veteran's Affairs Medical Center

    The Bronx, New York, 10468

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

    Torrance, California, 90502

  • The 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

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Whitman-Walker Health

    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

  • University of Massachusetts

    Worcester, Massachusetts

  • Westchester Digestive Disease Group

    Yonkers, New York, 10701

Other trials in United States

Australia25 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Flinders University

    Bedford Park, South Australia, 5042

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Canberra Specialist Centre

    Canberra, Australian Capital Territory

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2137

  • East Sydney Doctors

    Darlinghurst, New South Wales

  • Holdsworth House Medical Practice

    Darlinghurst, New South Wales

  • St Vincent's Public Hospital Sydney

    Darlinghurst, New South Wales

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Footscray Hospital

    Footscray, Victoria, 3011

  • Fremantle Hospital

    Fremantle, Western Australia

  • Greenslopes Private Hospital

    Greenslopes, 4102

  • Austin Health

    Heidelberg, Victoria, 3084

  • Royal Brisbane & Women's Hospital

    Herston, QLD 4029

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Alfred Hospital

    Melbourne, Victoria

  • Fiona Stanley Hospital

    Murdoch, Western Australia

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal Perth Hospital

    Perth, 6001

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

France25 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

  • Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie

    Lille, Hauts-de-France

  • Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

    Limoges, Limousin

  • 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

    Paris, 75010

  • Hôpital la Pitié Salpêtrière

    Paris, 75013

  • Hôpital Cochin

    Paris, 75679

  • Hôpital Saint-Antoine

    Paris, Île-de-France Region, 75012

  • CHU Pitié-Salpêtrière

    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 Tenon

    Paris, Île-de-France Region

  • Centre Hospitalier Universitaire Bordeaux Hôpital Haut-Lévêque

    Pessac, 33604

  • Hopital Pontchaillou

    Rennes, 35033

  • C.H.U. Strasbourg

    Strasbourg, 67091

  • CIC Hopital Purpan

    Toulouse, Midi-pyrenees, 31059

  • CIC Hopital Purpan

    Toulouse, Midi-pyrenees

  • Hopitaux De Brabois

    Vandœuvre-lès-Nancy, Limousin, Lorraine

  • Hôpital Paul Brousse

    Villejuif, Île-de-France Region

Other trials in France

Germany24 sites

  • Leber- and Studienzentrum am Checkpoint

    Berlin, 10969

  • EPIMED GmbH

    Berlin, 12157

  • Charité Universitätsmedizin Berlin

    Berlin, 13353

  • Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

    Berlin

  • Universitäts Bonn

    Bonn, 53105

  • Klinikum der Universität zu Köln

    Cologne, North Rhine-Westphalia

  • Medizinisches Versorgungszentrum

    Düsseldorf, North Rhine-Westphalia

  • Universitätsklinikum Düsseldorf

    Düsseldorf, North Rhine-Westphalia

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia

  • Universitätsklinikum Frankfurt

    Frankfurt

  • Infektiologikum Frankfurt

    Frankfurt am Main, Hesse

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hesse

  • Albert-Ludwigs-Universität

    Freiburg im Breisgau, Baden-Wurttemberg

  • PraxisZentrum für Gastroenterologie und Endokrinologie

    Freiburg im Breisgau, Baden-Wurttemberg

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

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

    Heidelberg, Baden-Wurttemberg

  • Gastroenterologische Gemeinschaftspraxis

    Herne, North Rhine-Westphalia

  • Gastroenterologische Gemeinschaftspraxis Kiel Preetzer

    Kiel, 24146

  • University of Leipzig

    Leipzig, 04103

  • Mainz University

    Mainz

  • Medizinische Klinik und Poliklinik III

    München, Bavaria

  • Centrum für Interdisziplinäre Medizin

    Münster, North Rhine-Westphalia

Other trials in Germany

Italy15 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 - Polo Universitario Luigi Saco

    Milan, 20157

  • 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

  • Instituto Nationale Per Le Malattie Infettive "Lazzaro Spallanzani"

    Roma, 00149

  • Fondazione Policlinico Tor Vergata

    Roma

  • Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino

Other trials in Italy

United Kingdom14 sites

  • University of Birmingham and Queen Elizabeth Hospital Birmingham

    Birmingham, England

  • Bristol Royal Infirmary

    Bristol, England

  • St George Hospital

    London, England, SW17 0QT

  • 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

  • Royal Free London NHS Foundation Trust

    London, England

  • North Manchester General Hospital

    Manchester, England

  • Nottingham University Hospitals NHS Trust

    Nottingham, England

  • John Radcliffe Hospital

    Oxford, England, OX3 9DU

  • Derriford Hospital

    Plymouth, England

  • Queen Alexandra Hospital

    Portsmouth, England, PO6 3LY

  • Southampton University Hospitals NHS Trust, Southampton General Hospital

    Southampton, England

Other trials in United Kingdom

Spain13 sites

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08036

  • Hospital Clinic I Provincial de Barcelona

    Barcelona

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Ramón y Cajal

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Puerta de Hierro Majadahonda

    Majadahonda, Madrid

  • Hospital Clínico Universitario Virgen de la Victoria

    Málaga, Malaga

  • Hospital Universitario Marques de Valdecilla

    Santander

  • Hospital Universitario Nuestra Señora de Valme

    Seville, 41014

  • Hospital Universitario Nuestra Señora de Valme

    Seville

  • Hospital General Universitario de Valencia

    Valencia

Other trials in Spain

Canada12 sites

  • University of Calgary Liver Unit

    Calgary, Alberta, T2N 4Z6

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2CB

  • Centre Hospitalier de L'Universite de Montreal (CHUM)

    Montreal, Quebec, H1T 2M4

  • Ottawa General Hospital

    Ottawa, Ontario

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • Liver and Intestinal Research Center

    Vancouver, British Columbia, V5Z 1H2

  • GIRI GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

  • Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia

  • Vancouver Infectious Disease Research and Care Centre

    Vancouver, British Columbia

  • University of Manitoba

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

New Zealand7 sites

  • Christchurch Hospital

    Christchurch, 8011

  • Dunedin Hospital

    Dunedin

  • Auckland Clinical Studies Limited

    Grafton, Auckland, 1010

  • Auckland City Hospital

    Grafton, Auckland

  • Urosurgery

    Hamilton

  • Wellington Hospital

    Newtown, WGN, 6021

  • Bay of Plenty Clinical School

    Tauranga, Bay of Plenty

Other trials in New Zealand

Poland6 sites

  • Wojewódzki Szpital Specjalistyczny im. Kazimierza Dluskiego w Bialymstoku

    Bialystok, Podlaskie Voivodeship

  • Szpital Specjalistyczny w Chorzowie

    Chorzów, Silesian Voivodeship

  • Spzoz Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego W Lodzi

    Lodz, 91-347

  • ID Clinic Arkadiusz Pisula

    Mysłowice, Silesian Voivodeship

  • SP ZOZ Wojewódzki Szpital Zakazny

    Warsaw, Masovian Voivodeship

  • Centrum Badan Klinicznych

    Wroclaw, Lower Silesian Voivodeship

Other trials in Poland

Belgium4 sites

  • Ziekenhuis Netwerk Antwerpen Campus Stuivenberg

    Antwerp

  • Cliniques Universitaires Saint Luc

    Brussels

  • Université Libre de Bruxelles Hôpital Erasme

    Brussels

  • AZ Groeninge Kortrijk

    Kortrijk

Other trials in Belgium

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

Sweden4 sites

  • Sahlgrenska Universitetssjukhuset, Östra Sjukhus

    Gothenburg, 41685

  • Skånes Universitetssjukhus i Lund

    Lund

  • Skånes Universitetssjukhus,

    Malmö

  • Karolinska University Hospital Huddinge

    Stockholm

Other trials in Sweden

Austria3 sites

  • Medizinische Universität Graz

    Graz, Styria

  • Medizinische Universität Wien

    Vienna, State of Vienna

  • Wilhelminenspital der Stadt Wien

    Vienna, State of Vienna

Other trials in Austria

Czechia3 sites

  • Slezska nemocnice v Opave, Infekcni oddeleni

    Opava, 746 01

  • Klin med, s.r.o.

    Prague, 169 02

  • Remedis, s.r.o.

    Prague, Praha 4

Other trials in Czechia

Estonia2 sites

  • West Tallinn Central Hospital

    Talinn

  • Tartu University Hospital

    Tartu

Other trials in Estonia

Puerto Rico2 sites

  • Clinical Research Puerto Rico

    San Juan, PR

  • Fundacion De Investigacion De Diego

    San Juan, 927

Other trials in Puerto Rico

About this study

Official title: A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection

This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.

Keywords
Hepatitis C, HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Tegobuvir, Registry, HCV RNA, Treatment experienced, Treatment naive, GS 9451, GS 5885, GS 7977, GS 5816, 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 maintaining SVR at Week 144 by treatment regimen

    Measured: Week 144

Secondary outcomes (5)

  1. Proportion of participants with detectable HCV RNA due to reemergence of preexisting virus through Week 144 by treatment regimen

    Measured: Up to 144 weeks

  2. Proportion of participants with detectable HCV resistance mutations through Week 144 by treatment regimen

    Measured: Up to 144 weeks

  3. Proportion of participants with detectable HCV RNA due to reinfection through Week 144 by treatment regimen

    Measured: Up to 144 weeks

  4. 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 144 weeks

  5. 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 start13 Apr 2012
  3. Primary completion28 Mar 2017
  4. Study completion8 Jan 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
6,625 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01457755
Sponsor's protocol ID
GS-US-248-0122
Other IDs
2011-000945-19
Status last verified
Aug 2018
First submitted
4 Oct 2011
Last updated
31 Aug 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

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, Chronic, run by Gilead Sciences at 325 sites in 17 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 325 sites in United States, Australia, France, Germany, Italy and 12 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 maintaining SVR at Week 144 by treatment regimen (time frame: Week 144). 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 NCT01457755, which also lists 1 linked publication.

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 31 Aug 2018.

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