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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02292706
Other study ID # GS-US-337-1431
Secondary ID 2014-001249-26
Status Terminated
Phase
First received
Last updated
Start date December 29, 2014
Est. completion date December 31, 2021

Study information

Verified date December 2022
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
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
Other:
Ineligible parent treatment
Participants were enrolled from ineligible parent treatment group.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  New Zealand,  Puerto Rico,  Spain,  United Kingdom, 

References & Publications (8)

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.

Outcome

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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