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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: Completed Phase 2 study of Hepatocellular Carcinoma and Hepatitis C, sponsored by Gilead Sciences.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

pTVR was defined as HCV RNA \< the lower limit of quantification (LLOQ, ie, 25 mL/IU) at Week 12 after transplant.

Conditions Studied

Hepatocellular Carcinoma Hepatitis C

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

FieldValue
Enrollment Target 61 participants
Start Date 2012-03
Est. Completion 2014-10
Phase Phase 2
Gilead Sciences

504 total trials

What the finished NCT01559844 record still lists

NCT01559844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (76% lower).

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 lists 15 locations in 10 states (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.

Learn More About Clinical Trials

Similar trials for Hepatocellular Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01559844's enrollment target sits among peer trials

61 76th of 145 higher than 70 of 145 other Hepatocellular Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01559844, the US trial registry maintained by the National Library of Medicine. NCT01559844 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.