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Intravenous Interferon During the Anhepatic Phase of Liver Transplantation and Prevention of Recurrence of Hepatitis C Virus

This study has been completed.
American College of Gastroenterology
Information provided by (Responsible Party):
Mark W. Russo, Carolinas Healthcare System Identifier:
First received: August 30, 2010
Last updated: March 31, 2014
Last verified: March 2014
The main goal of this study is to prevent liver allograft infection with Hepatitis C virus in hepatitis C positive patients undergoing liver transplantation. The hypothesis is that patients who receive ribavirin immediately before transplant and intravenous interferon alfa 2b during the anhepatic phase(while the liver is removed)will have sustained virologic response post liver transplant.

Condition Intervention
Hepatitis C
Liver Transplant
Drug: IV interferon

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravenous Interferon During the Anhepatic Phase of Liver Transplantation and Prevention of Recurrence of Hepatitis C Virus

Resource links provided by NLM:

Further study details as provided by Mark W. Russo, Carolinas Healthcare System:

Primary Outcome Measures:
  • HCV RNA result [ Time Frame: Measured at specified intervals up to one year post transplant ]
    Will measure HCV RNA levels pre-transplant, during and post-transplant up to one year.

Enrollment: 15
Study Start Date: October 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV interferon
IV interferon oral ribavirin
Drug: IV interferon
IV interferon 5MU during anhepatic phase
No Intervention: no treatment
no treatment


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • liver transplant for hepatitis c

Exclusion Criteria:

  • allergy to interferon
  Contacts and Locations
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Please refer to this study by its identifier: NCT01192698

Sponsors and Collaborators
Carolinas Healthcare System
American College of Gastroenterology
Principal Investigator: Mark W Russo, MD, MPH Carolinas Healthcare System
  More Information

Responsible Party: Mark W. Russo, Medical Director of Liver Transplantation, Carolinas Healthcare System Identifier: NCT01192698     History of Changes
Other Study ID Numbers: 04-05-09A
Study First Received: August 30, 2010
Last Updated: March 31, 2014

Keywords provided by Mark W. Russo, Carolinas Healthcare System:
hepatitis c
liver transplant
hepatitis C after liver transplant

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Disease Attributes
Pathologic Processes
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents processed this record on May 25, 2017