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Brief Title: Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant
Official Title: 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
Study ID: NCT01559844
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
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
Mount Sinai Medical Center, Miami Beach, Florida, United States
University of Miami, Miami, 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
Columbia University, New York, New York, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Baylor Health Care System, Dallas, Texas, United States
Auckland Clinical Studies, Auckland, , New Zealand
Liver Unit Clinica University de Navara, Pamplona, , Spain
Name: Jill Denning, MA
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR