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

This study has been completed.
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Mark W. Russo, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01192698
First received: August 30, 2010
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 Carolinas Healthcare System:

Primary Outcome Measures:
  • HCV RNA result [ Time Frame: Measured at specified intervals up to one year post transplant ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • liver transplant for hepatitis c

Exclusion Criteria:

  • allergy to interferon
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192698

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

No publications provided

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

Keywords provided by Carolinas Healthcare System:
hepatitis c
liver transplant
hepatitis C after liver transplant

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Recurrence
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Disease Attributes
Pathologic Processes
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2014