Hepatitis C Virus Infection Clinical Trial
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
Verified date | December 2022 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Terminated |
Enrollment | 1609 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
Australia | St Vincents Hospital Sydney | Fitzroy | Victoria |
Australia | Fiona Stanley Hospital | Fremantle | Western Australia |
Australia | Austin Health | Heidelberg | Victoria |
Australia | Royal Brisbane & Women's Hospital | Herston | Queensland |
Australia | Monash Medical Centre Clayton Campus | Melbourne | Victoria |
Australia | Royal Perth Hospital | Perth | Western Australia |
Australia | The Alfred Hospital | Prahran | Victoria |
Australia | Kirby Institute | Sydney | New South Wales |
Australia | Westmead Hospital | Westmead | New South Wales |
Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
Canada | University of Calgary | Calgary | Alberta |
Canada | University of Alberta | Edmonton | |
Canada | London Health Sciences Centre - University Campus | London | Ontario |
Canada | CRCHUM | Montréal | Quebec |
Canada | University Health Network | Toronto | Ontario |
Canada | GI Research Institute | Vancouver | British Columbia |
Canada | Vancouver Infectious Disease Research and Care Centre | Vancouver | British Columbia |
France | Hopital Haut Leveque | Bordeaux | |
France | CHU Estaing | Clermont Ferrand | |
France | Hôpital Beaujon | Clichy | |
France | Hopital Henri Mondor | Creteil Cedex | |
France | CHU de Grenoble- Hopital Michallon | Grenoble Cedex 9 | |
France | Hôpital Universitaire Dupuytren | Limoges Cedex | Limousin |
France | Hopital Saint Joseph | Marseille Cedex 08 | Provence Alpes Cote D'Azur |
France | CHU Montpellier - Hopital St. Eloi | Montpellier Cedex 05 | Languedoc-Rousillon |
France | Groupe Hospitalier Archet I Et II | Nice Cedex 3 | Provence Alpes Cote D'Azu |
France | Hôpital de la Croix Rousse | Paris | |
France | Hopital de La Pitié-Salpêtrière | Paris | Ile De France |
France | Hopital Tenon | Paris | |
France | Hopital Cochin | Paris, Cedex 14 | |
France | Hôpital Pontchaillou | Rennes | Bretagne |
France | Hôpitaux Universitaires de Strasbourg | Strasbourg | |
France | Hopital Purpan | Toulouse | Midi-Pyrenees |
France | CHU de Nancy-Hopital Brabois Adulte | Vandoeuvre les Nancy | |
France | Hôpital Paul Brousse | Villejuif | |
Germany | Klinikum der Johann Wolfgang Goethe Universitat | Frankfurt am Main | |
Germany | Asklepios Klinik St. Georg | Hamburg | |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Universitatsklinikum Koln | Koln | |
Germany | Technische Universität München | Mücheln | |
Italy | Azienda Ospedaliera Ospedale Niguarda Cà Granda | Milano | |
Italy | Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milano | |
Italy | Ospedale Casa Sollievo Della Sofferenza IRCCS | San Giovanni Rotondo | |
Italy | Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | |
New Zealand | Auckland Clinical Studies Ltd | Auckland | North Island |
New Zealand | Christchurch Hospital | Christchurch | South Island |
New Zealand | Waikato Hospital | Hamilton | North Island |
Puerto Rico | Fundacion de Investigation de Diego | San Juan | |
Spain | Hospital Clinic de Barcelona | Barcelona | |
Spain | Hospital Universitario Vall d'Hebron | Barcelona | |
Spain | Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid |
Spain | Hospital Virgen de Valme | Sevilla | |
Spain | Hospital Universitari i Politecnic La Fe de Valencia | Valencia | |
United Kingdom | Gartnavel General Hospital | Glasgow | Scotland |
United Kingdom | 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 | Queen Alexandra Hospital | Portsmouth | |
United States | University of Michigan Medical Center | Ann Arbor | Michigan |
United States | INOVA Fairfax Hospital | Annandale | Virginia |
United States | The North Texas Clinical Research Institute | Arlington | Texas |
United States | Asheville Gastroenterology Associates, PA | Asheville | North Carolina |
United States | Atlanta Gastroenterology Associates | Atlanta | Georgia |
United States | Atlanta Medical Center | Atlanta | Georgia |
United States | Emory University Hospital Midtown | Atlanta | Georgia |
United States | University of Colorado | Aurora | Colorado |
United States | Mercy Medical Center | Baltimore | Maryland |
United States | Binghamton Gastroenterology Associates, PC | Binghamton | New York |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | BIDMC Liver Center | Boston | Massachusetts |
United States | Community Research Initiative of New England | Boston | Massachusetts |
United States | Digestive Disease Associates, PA | Catonsville | Maryland |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Baylor Endocrine Center | Dallas | Texas |
United States | North Texas Research Institute | Dallas | Texas |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Cumberland Research Associates, LLC | Fayetteville | North Carolina |
United States | UF Hepatology Research at CTRB | Gainesville | Florida |
United States | Gastroenterology Center of the MidSouth, P.C. | Germantown | Tennessee |
United States | ID Care, Inc | Hillsborough | New Jersey |
United States | St. Luke's Episcopal Hospital | Houston | Texas |
United States | Indiana University | Indianapolis | Indiana |
United States | Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana |
United States | Borland-Groover Clinic | Jacksonville | Florida |
United States | Kansas City Research Institute, LLC | Kansas City | Missouri |
United States | University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas |
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 | Johns Hopkins Hospital/University | Lutherville | Maryland |
United States | North Shore Health Inc. | Manhasset | New York |
United States | Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia |
United States | University of Miami Miller School of Medicine | Miami | Florida |
United States | University of Minnesota Medical Center | Minneapolis | Minnesota |
United States | Delta Research Partners | Monroe | Louisiana |
United States | Intermountain Medical Center | Murray | Utah |
United States | Nashville Gastrointestinal Specialists, Inc. | Nashville | Tennessee |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
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 | Bon Secours St. Mary's Hospital of Richmond | Newport News | Virginia |
United States | Digestive and Liver Disease Specialists | Norfolk | Virginia |
United States | Orlando Immunology Center | Orlando | Florida |
United States | The Liver Center | Pasadena | California |
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 | Inland Empire Liver Foundation | Rialto | California |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of California, Davis Medical Center | Sacramento | California |
United States | Saint Louis University | Saint Louis | Missouri |
United States | Minnesota Gastroenterology, PA | Saint Paul | Minnesota |
United States | The Texas Liver Institute | San Antonio | Texas |
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 | Southwest CARE Center | Santa Fe | New Mexico |
United States | Harborview Medical Center | Seattle | Washington |
United States | Virginia Mason Medical Center | Seattle | Washington |
United States | Stanford University | Stanford | California |
United States | Tampa General Hospital | Tampa | Florida |
United States | Georgetown University Medical Center | Washington | District of Columbia |
United States | Whitman-Walker Health | Washington | District of Columbia |
United States | South Florida Center of Gastroenterology | Wellington | Florida |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States, Australia, Canada, France, Germany, Italy, New Zealand, Puerto Rico, Spain, United Kingdom,
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. — View 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.
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. 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.
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 | SVR at Week 240 was defined as HCV RNA< lower limit of quantification (LLOQ i.e., 15 or 25 international units per milliliter [IU/mL]) or last available HCV RNA< LLOQ with no subsequent follow-up values at Week 240 after enrollment in this registry study. Percentage of participants who maintained SVR status by Week 240 was estimated using a Kaplan-Meier model. | Week 240 | |
Primary | Percentage of Participants With Any Liver-Associated Events | The percentage of participants with any liver-associated events since registry start (enrollment) through Week 240 was estimated using a Kaplan-Meier model. | Enrollment up to 240 weeks | |
Primary | Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240 | Participants with de novo HCC since registry start were defined as participants who had not been identified with HCC prior to registry start and only had HCC since registry start. The percentage of participants who developed de novo HCC through Week 240 was estimated using a Kaplan-Meier model. | Enrollment up to 240 weeks | |
Secondary | Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240 | Enrollment up to 240 weeks | ||
Secondary | Number of Participants With Detectable HCV Resistance Mutations Through Week 240 | Enrollment up to 240 weeks | ||
Secondary | Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240 | Reinfection was defined as HCV RNA > LLOQ on 2 samples collected at least 1 week apart with a different virus than that present prior to treatment baseline in the parent study. | Enrollment up to 240 weeks |
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