A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
NCT ID: NCT02292706
Last Updated: 2023-10-04
Study Results
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View full resultsBasic Information
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TERMINATED
1609 participants
OBSERVATIONAL
2014-12-29
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SOF+RBV
Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) will be followed up to 5 years.
Sofosbuvir
Exposure of interest for participants who received sofosbuvir in a previous Gilead study for chronic HCV infection.
Ribavirin
LDV/SOF
Participants who were previously treated with ledipasvir/sofosbuvir (LDV/SOF) will be followed up to 5 years.
LDV/SOF
Exposure of interest for participants who received LDV/SOF in a previous Gilead study for chronic HCV infection.
LDV/SOF+RBV
Participants who were previously treated with LDV/SOF along with ribavirin will be followed up to 5 years.
Ribavirin
LDV/SOF
Exposure of interest for participants who received LDV/SOF in a previous Gilead study for chronic HCV infection.
SOF/VEL
Participants who were previously treated with sofosbuvir/velpatasvir (SOF/VEL) will be followed up to 5 years.
SOF/VEL
Exposure of interest for participants who received SOF/VEL in a previous Gilead study for chronic HCV infection.
SOF/VEL+RBV
Participants who were previously treated with SOF/VEL along with RBV will be followed up to 5 years.
Ribavirin
SOF/VEL
Exposure of interest for participants who received SOF/VEL in a previous Gilead study for chronic HCV infection.
SOF/VEL/VOX
Participants who were previously treated with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) with or without RBV will be followed up to 5 years.
Ribavirin
SOF/VEL/VOX
Exposure of interest for participants who received SOF/VEL/VOX in a previous Gilead study for chronic HCV infection.
Other SOF-Based
Participants who previously received other SOF based regimen will be followed up to 5 years.
Other SOF-Based Regimen
The other SOF-based regimens may have included the following:
* BMS-790052 (Daclatasvir) + GS-7977 (SOF) with or without RBV
* LDV/SOF + GS-9669, GS-7977 (SOF) + with or without RBV + TMC-435 (Simeprevir)
* LDV/SOF + Vedroprevir (VDV), LDV/SOF + GS-9669 (250 mg and 500 mg)
* LDV/SOF + VDV + RBV
* Simeprevir + SOF
* TMC-435 (Simeprevir) + VEL/SOF
Enrolled From Ineligible Parent Treatment Group
Participants were enrolled from ineligible parent treatment group.
Ineligible parent treatment
Participants were enrolled from ineligible parent treatment group.
Interventions
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Sofosbuvir
Exposure of interest for participants who received sofosbuvir in a previous Gilead study for chronic HCV infection.
Ribavirin
LDV/SOF
Exposure of interest for participants who received LDV/SOF in a previous Gilead study for chronic HCV infection.
SOF/VEL
Exposure of interest for participants who received SOF/VEL in a previous Gilead study for chronic HCV infection.
SOF/VEL/VOX
Exposure of interest for participants who received SOF/VEL/VOX in a previous Gilead study for chronic HCV infection.
Other SOF-Based Regimen
The other SOF-based regimens may have included the following:
* BMS-790052 (Daclatasvir) + GS-7977 (SOF) with or without RBV
* LDV/SOF + GS-9669, GS-7977 (SOF) + with or without RBV + TMC-435 (Simeprevir)
* LDV/SOF + Vedroprevir (VDV), LDV/SOF + GS-9669 (250 mg and 500 mg)
* LDV/SOF + VDV + RBV
* Simeprevir + SOF
* TMC-435 (Simeprevir) + VEL/SOF
Ineligible parent treatment
Participants were enrolled from ineligible parent treatment group.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have either previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon OR at pre-selected sites only, have received an all-oral SOF-based regimen outside a clinical study. These individuals must have documentation of the regimen, start and end of treatment dates (month and year), and of having achieved SVR12.
* Have achieved SVR either in a Gilead-sponsored study, as defined in the treatment protocol OR for individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, SVR will be defined as HCV RNA \< lower limit of quantification (LLOQ) approximately 12 weeks following last dose of treatment.
* Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen OR individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, will have had cirrhosis confirmed prior to initiation of HCV treatment.
Exclusion Criteria
* History of clinically-significant illness or any other major medical disorder that may interfere with the follow-up, assessments, or compliance with the protocol
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Scripps Clinic Medical Group
La Jolla, California, United States
V.A. Long Beach Medical Center
Long Beach, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Kaiser Permanente Medical Center
Los Angeles, California, United States
Tarrant County ID Associates
Los Angeles, California, United States
The Liver Center
Pasadena, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Kaiser Permanente
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
University of California at San Francisco Medical Center
San Francisco, California, United States
Stanford University
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Whitman-Walker Health
Washington D.C., District of Columbia, United States
UF Hepatology Research at CTRB
Gainesville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
South Florida Center of Gastroenterology
Wellington, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Atlanta Medical Center
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
Delta Research Partners
Monroe, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Digestive Disease Associates, PA
Catonsville, Maryland, United States
Johns Hopkins Hospital/University
Lutherville, Maryland, United States
Community Research Initiative of New England
Boston, Massachusetts, United States
BIDMC Liver Center
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Minnesota Gastroenterology, PA
Saint Paul, Minnesota, United States
Kansas City Research Institute, LLC
Kansas City, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
ID Care, Inc
Hillsborough, New Jersey, United States
Southwest CARE Center
Santa Fe, New Mexico, United States
Binghamton Gastroenterology Associates, PC
Binghamton, New York, United States
North Shore Health Inc.
Manhasset, New York, United States
Columbia University Medical Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
New York University Medical Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Gastroenterology Center of the MidSouth, P.C.
Germantown, Tennessee, United States
Nashville Gastrointestinal Specialists, Inc.
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The North Texas Clinical Research Institute
Arlington, Texas, United States
Baylor Endocrine Center
Dallas, Texas, United States
North Texas Research Institute
Dallas, Texas, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
The Texas Liver Institute
San Antonio, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
INOVA Fairfax Hospital
Annandale, Virginia, United States
Bon Secours St. Mary's Hospital of Richmond
Newport News, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Kirby Institute
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
St Vincents Hospital Sydney
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Monash Medical Centre Clayton Campus
Melbourne, Victoria, Australia
The Alfred Hospital
Prahran, Victoria, Australia
Fiona Stanley Hospital
Fremantle, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
University of Calgary
Calgary, Alberta, Canada
GI Research Institute
Vancouver, British Columbia, Canada
Vancouver Infectious Disease Research and Care Centre
Vancouver, British Columbia, Canada
London Health Sciences Centre - University Campus
London, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
CRCHUM
Montreal, Quebec, Canada
University of Alberta
Edmonton, , Canada
Hôpital Pontchaillou
Rennes, Brittany Region, France
CHU Montpellier - Hopital St. Eloi
Montpellier, Languedoc-Rousillon, France
Hôpital Universitaire Dupuytren
Limoges, Limousin, France
Hopital Purpan
Toulouse, Midi-Pyrenees, France
Groupe Hospitalier Archet I Et II
Nice, Provence Alpes Cote D'Azu, France
Hopital Saint Joseph
Marseille, Provence-Alpes-Côte d'Azur Region, France
Hopital Haut Leveque
Bordeaux, , France
CHU Estaing
Clermont-Ferrand, , France
Hôpital Beaujon
Clichy, , France
Hopital Henri Mondor
Créteil, , France
CHU de Grenoble- Hopital Michallon
Grenoble, , France
Hopital Cochin
Paris, , France
Hopital Tenon
Paris, , France
Hôpital de la Croix Rousse
Paris, , France
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
CHU de Nancy-Hopital Brabois Adulte
Vandœuvre-lès-Nancy, , France
Hôpital Paul Brousse
Villejuif, , France
Hopital de La Pitié-Salpêtrière
Paris, Île-de-France Region, France
Universitatsklinikum Koln
Cologne, , Germany
Klinikum der Johann Wolfgang Goethe Universitat
Frankfurt am Main, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Technische Universität München
Mücheln, , Germany
Azienda Ospedaliera Ospedale Niguarda Cà Granda
Milan, , Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, , Italy
Auckland Clinical Studies Ltd
Auckland, North Island, New Zealand
Waikato Hospital
Hamilton, North Island, New Zealand
Christchurch Hospital
Christchurch, South Island, New Zealand
Fundacion de Investigation de Diego
San Juan, , Puerto Rico
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Virgen de Valme
Seville, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Barts Health NHS Trust
London, England, United Kingdom
Kings College Hospital
London, England, United Kingdom
St Georges University of London
London, England, United Kingdom
North Manchester General Hospital
Manchester, England, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, England, United Kingdom
Gartnavel General Hospital
Glasgow, Scotland, United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Countries
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References
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Dunn W, Koestler D, Ni L, Kersey K, Kreter B, Hammond K et al. Cirrhosis regression based on both Enhanced Liver Fibrosis (ELF) and Fibrotest after Direct-acting Hepatitis C therapeutics corresponds to a lower incidence rate of hepatocellular carcinoma below the cost-effective threshold for surveillance [Poster 1289]. The International Liver Congress™ EASL - European Association for the Study of the Liver (EASL); 2021 23-26 June.
Fan R, Papatheodoridis G, Sun J, Innes H, Toyoda H, Xie Q, Mo S, Sypsa V, Guha IN, Kumada T, Niu J, Dalekos G, Yasuda S, Barnes E, Lian J, Suri V, Idilman R, Barclay ST, Dou X, Berg T, Hayes PC, Flaherty JF, Zhou Y, Zhang Z, Buti M, Hutchinson SJ, Guo Y, Calleja JL, Lin L, Zhao L, Chen Y, Janssen HLA, Zhu C, Shi L, Tang X, Gaggar A, Wei L, Jia J, Irving WL, Johnson PJ, Lampertico P, Hou J. aMAP risk score predicts hepatocellular carcinoma development in patients with chronic hepatitis. J Hepatol. 2020 Dec;73(6):1368-1378. doi: 10.1016/j.jhep.2020.07.025. Epub 2020 Jul 21.
Jacobson I, Muir AJ, Lawitz EJ, Gane E, Conway B, Ruane PJ, et al. Course of Cirrhosis Regression: Lessons From Patients With HCV Cirrhosis Following Successful Sofosbuvir-Based Treatment [Poster 537]. AASLD: The Liver Meeting® 2019, November 11-15.
Mangia A, Lawitz E, Gane E Conway B, Ruane PJ, Abergel A, et al. Long-Term Follow-up of Patients with Chronic HCV Infection and Compensated or Decompensated Cirrhosis Following Treatment with Sofosbuvir-Based Regimens. The International Liver Congress™ EASL - European Association for the Study of the Liver (EASL); 2018 April 11-15.
Muir AJ, Buti M, Nahass R, Agarwal K, Gane EJ, Strasser SI, et al. Long-term Follow-up of Patients With Chronic HCV Infection and Compensated or Decompensated Cirrhosis Following Treatment With Sofosbuvir-Based Regimens [Poster 880]. AASLD: The Liver Meeting® 2019, November 11-15.
Reddy KR, Bourlière M, Agarwal K, Lawitz E, Osinusi A, Kersey K, et al. Sustained Viral Response Following Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C and the Risk of Hepatocellular Carcinoma [Poster FRI-185]. The International Liver Congress™ EASL - European Association for the Study of the Liver (EASL); 2017 19-23 April.
Reddy R, Muir A, Naggie S, Lawitz E, Gane E, Conway B et al. Noninvasive Tests of Fibrosis and Risk of Liver-Related Complications: Lessons From Patients With HCV Cirrhosis Following Successful Sofosbuvir-Based Treatment [Poster 452]. The International Liver Congress™ EASL - European Association for the Study of the Liver (EASL); 2020 27-29 August.
Reddy R, Muir A, Naggie S, Lawitz E, Gane E, Conway B et al. Non-invasive tests of fibrosis and risk of liver-related complications: observations following successful sofosbuvir-based treatment in patients with HCV cirrhosis. J Hepatology 2020;73: S401-S652.
Younossi ZM, Racila A, Muir A, Bourliere M, Mangia A, Esteban R, Zeuzem S, Colombo M, Manns M, Papatheodoridis GV, Buti M, Chokkalingam A, Gaggar A, Nader F, Younossi I, Henry L, Stepanova M. Long-term Patient-Centered Outcomes in Cirrhotic Patients With Chronic Hepatitis C After Achieving Sustained Virologic Response. Clin Gastroenterol Hepatol. 2022 Feb;20(2):438-446. doi: 10.1016/j.cgh.2021.01.026. Epub 2021 Jan 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2014-001249-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-337-1431
Identifier Type: -
Identifier Source: org_study_id
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