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An Open-Label Study to Explore the Clinical Efficacy of GS-7977 With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant
The primary objective is to determine if the administration of a combination of sofosbuvir (SOF; GS-7977; PSI-7977) and ribavirin (RBV) to HCV-infected adults with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation could prevent post-transplant re-infection as determined by a sustained post-transplant virological response (HCV RNA \< LLoQ) at 12 weeks post-transplant. Participants will enroll in the pretransplant treatment phase (24 or 48 weeks). Participants enrolling for 24 weeks in the pretransplant treatment phase may receive treatment for up to an additional 24 weeks in the pretransplant retreatment phase. Participants enrolling for 48 weeks in the pretransplant treatment will have a second baseline at Week 24 for combined analysis in the pretransplant retreatment phase. Participants who undergo liver transplant will stop all study drug 24 hours prior to transplant, and enter a 48-week follow-up phase to monitor for recurrent HCV infection.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UCLA Medical Center-The Pfleger Liver Institute
Los Angeles, California, United States
UC San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
University of Miami
Miami, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. Louis University Hospital
St Louis, Missouri, United States
Start Date
March 1, 2012
Primary Completion Date
May 1, 2014
Completion Date
October 1, 2014
Last Updated
July 27, 2016
61
ACTUAL participants
Sofosbuvir
DRUG
Ribavirin
DRUG
Lead Sponsor
Gilead Sciences
NCT06066138
NCT07485114
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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