Intravenous Interferon During Liver Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01192698
Recruitment Status : Completed
First Posted : September 1, 2010
Results First Posted : August 7, 2017
Last Update Posted : August 7, 2017
American College of Gastroenterology
Information provided by (Responsible Party):
Mark W. Russo, Carolinas Healthcare System

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C Cirrhosis Drug: IV interferon Not Applicable

Detailed Description:
The study is evaluating intravenous interferon given during the anhepatic phase of lvier transplant. Ribavirin was given as well. Serial measurements for HCV RNA were determined 12, 24 72, 96 hrs and 4 weeks after liver transplant.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Interferon During the Anhepatic Phase of Liver Transplantation and Prevention of Recurrence of Hepatitis C Virus
Study Start Date : October 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Experimental: IV interferon
IV interferon oral ribavirin
Drug: IV interferon
IV interferon 5MU during anhepatic phase
No Intervention: Standard of care
standard of care

Primary Outcome Measures :
  1. HCV RNA Result [ Time Frame: 4 weeks after liver transplant ]
    Will measure mean HCV RNA levels 4 weeks after liver transplant

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01192698

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

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
First Posted: September 1, 2010    Key Record Dates
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mark W. Russo, Carolinas Healthcare System:
hepatitis C

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
Pathologic Processes
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents