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NCT01559844 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant
A Phase 2 study of Hepatocellular Carcinoma and Hepatitis C, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 15
- Study locations
NCT01559844 is a Phase 2 study of Hepatocellular Carcinoma and Hepatitis C that has completed, run by Gilead Sciences. The registered enrollment target is 61 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (76% lower). The trial reports 15 study locations across 10 states.
The verdict
NCT01559844, a Phase 2 study of Hepatocellular Carcinoma and Hepatitis C, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 15
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Ribavirin
- DRUG Sofosbuvir
Study Locations (15)
California
- UCLA Medical Center-The Pfleger Liver Institute - Los Angeles
- UC San Diego - San Diego
- University of California, San Francisco - San Francisco
Florida
- University of Miami - Miami
- Mount Sinai Medical Center - Miami Beach
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Lahey Clinic Medical Center - Burlington
Other
- Auckland Clinical Studies - Auckland
- Liver Unit Clinica University de Navara - Pamplona
Colorado
- University of Colorado - Aurora
Michigan
- Henry Ford Hospital - Detroit
Missouri
- St. Louis University Hospital - St Louis
New York
- Columbia University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2012-03 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01559844
The ClinicalTrials.gov registry entry for NCT01559844 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (76% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Ribavirin is the first listed.
NCT01559844 reports 15 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01559844 about?
NCT01559844 is a clinical study titled "Efficacy of Sofosbuvir 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-inf...
What is the current status of trial NCT01559844?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2012-03. Estimated completion is 2014-10.
What conditions does trial NCT01559844 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Hepatitis C.
What interventions are being tested in trial NCT01559844?
The interventions under investigation include: Ribavirin (DRUG), Sofosbuvir (DRUG).
Who is sponsoring clinical trial NCT01559844?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01559844 being conducted?
This trial has 15 study locations across California, Colorado, Florida, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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