Clinical trial NCT02292706: 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
Official title: A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C Virus Infection
Keywords: HCV Cirrhosis registry
Cirrhosis
Hepatitis C
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-11-17
Enrollment: 1609
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with cirrhosis who have achieved an SVR after receiving a SOF-based regimen without interferon (IFN) while participating in a Gilead-sponsored HCV study. In addition, participants with cirrhosis who have achieved SVR after an all-oral SOF-based regimen outside a clinical study may be eligible to enroll in this registry at sites preselected by Gilead.

Brief summary: The primary objective of this registry study is to assess the durability of sustained virologic response (SVR) and clinical progression or regression of liver disease including the incidence of hepatocellular carcinoma following SVR in participants with cirrhosis after treatment with a sofosbuvir-based regimen for HCV infection.


Eligibility criteria: Key Inclusion Criteria:

* Willing and able to provide written informed consent
* 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.

Key Exclusion Criteria:

* Individuals planning to initiate a new course of HCV therapy, including approved products and any investigational agents, during the course of this Registry
* History of clinically-significant illness or any other major medical disorder that may interfere with the follow-up, assessments, or compliance with the protocol

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

Primary outcomes:
measure: Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240
timeFrame: Week 240
measure: Percentage of Participants With Any Liver-Associated Events
timeFrame: Enrollment up to 240 weeks
measure: Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240
timeFrame: Enrollment up to 240 weeks
Secondary outcomes:
measure: Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240
timeFrame: Enrollment up to 240 weeks
measure: Number of Participants With Detectable HCV Resistance Mutations Through Week 240
timeFrame: Enrollment up to 240 weeks
measure: Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240
timeFrame: Enrollment up to 240 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: La Jolla
country: United States
facility: Scripps Clinic Medical Group
state: California
city: Long Beach
country: United States
facility: V.A. Long Beach Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Los Angeles
country: United States
facility: Tarrant County ID Associates
state: California
city: Pasadena
country: United States
facility: The Liver Center
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Whitman-Walker Health
state: District of Columbia
city: Gainesville
country: United States
facility: UF Hepatology Research at CTRB
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Wellington
country: United States
facility: South Florida Center of Gastroenterology
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Medical Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute, Inc.
state: Kansas
city: Monroe
country: United States
facility: Delta Research Partners
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Catonsville
country: United States
facility: Digestive Disease Associates, PA
state: Maryland
city: Lutherville
country: United States
facility: Johns Hopkins Hospital/University
state: Maryland
city: Boston
country: United States
facility: Community Research Initiative of New England
state: Massachusetts
city: Boston
country: United States
facility: BIDMC Liver Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: Minnesota Gastroenterology, PA
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Research Institute, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Hillsborough
country: United States
facility: ID Care, Inc
state: New Jersey
city: Santa Fe
country: United States
facility: Southwest CARE Center
state: New Mexico
city: Binghamton
country: United States
facility: Binghamton Gastroenterology Associates, PC
state: New York
city: Manhasset
country: United States
facility: North Shore Health Inc.
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Germantown
country: United States
facility: Gastroenterology Center of the MidSouth, P.C.
state: Tennessee
city: Nashville
country: United States
facility: Nashville Gastrointestinal Specialists, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Arlington
country: United States
facility: The North Texas Clinical Research Institute
state: Texas
city: Dallas
country: United States
facility: Baylor Endocrine Center
state: Texas
city: Dallas
country: United States
facility: North Texas Research Institute
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: San Antonio
country: United States
facility: The Texas Liver Institute
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Annandale
country: United States
facility: INOVA Fairfax Hospital
state: Virginia
city: Newport News
country: United States
facility: Bon Secours St. Mary's Hospital of Richmond
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Kirby Institute
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Fitzroy
country: Australia
facility: St Vincents Hospital Sydney
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre Clayton Campus
state: Victoria
city: Prahran
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: GI Research Institute
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver Infectious Disease Research and Care Centre
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre - University Campus
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montréal
country: Canada
facility: CRCHUM
state: Quebec
city: Edmonton
country: Canada
facility: University of Alberta
city: Rennes
country: France
facility: Hôpital Pontchaillou
state: Bretagne
city: Paris
country: France
facility: Hopital de La Pitié-Salpêtrière
state: Ile De France
city: Montpellier Cedex 05
country: France
facility: CHU Montpellier - Hopital St. Eloi
state: Languedoc-Rousillon
city: Limoges Cedex
country: France
facility: Hôpital Universitaire Dupuytren
state: Limousin
city: Toulouse
country: France
facility: Hopital Purpan
state: Midi-Pyrenees
city: Marseille Cedex 08
country: France
facility: Hopital Saint Joseph
state: Provence Alpes Cote D'Azur
city: Nice Cedex 3
country: France
facility: Groupe Hospitalier Archet I Et II
state: Provence Alpes Cote D'Azu
city: Bordeaux
country: France
facility: Hopital Haut Leveque
city: Clermont Ferrand
country: France
facility: CHU Estaing
city: Clichy
country: France
facility: Hôpital Beaujon
city: Creteil Cedex
country: France
facility: Hopital Henri Mondor
city: Grenoble Cedex 9
country: France
facility: CHU de Grenoble- Hopital Michallon
city: Paris, Cedex 14
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Tenon
city: Paris
country: France
facility: Hôpital de la Croix Rousse
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Vandoeuvre les Nancy
country: France
facility: CHU de Nancy-Hopital Brabois Adulte
city: Villejuif
country: France
facility: Hôpital Paul Brousse
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe Universitat
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Koln
country: Germany
facility: Universitatsklinikum Koln
city: Mücheln
country: Germany
facility: Technische Universität München
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo Della Sofferenza IRCCS
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies Ltd
state: North Island
city: Hamilton
country: New Zealand
facility: Waikato Hospital
state: North Island
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
state: South Island
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigation de Diego
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Sevilla
country: Spain
facility: Hospital Virgen de Valme
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: London
country: United Kingdom
facility: Barts Health NHS Trust
state: England
city: London
country: United Kingdom
facility: Kings College Hospital
state: England
city: London
country: United Kingdom
facility: St Georges University of London
state: England
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: England
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
state: Scotland
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.