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Intravenous Interferon During Liver Transplant

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01192698
First Posted: September 1, 2010
Last Update Posted: August 7, 2017
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.
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Mark W. Russo, Carolinas Healthcare System
  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 Cirrhosis Drug: IV interferon

Study Type: Interventional
Study Design: 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

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: 4 weeks after liver transplant ]
    Will measure mean HCV RNA levels 4 weeks after liver transplant


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: Standard of care
standard of care

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.
  Eligibility

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
Criteria

Inclusion Criteria:

  • liver transplant for hepatitis c

Exclusion Criteria:

  • allergy to interferon
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01192698


Sponsors and Collaborators
Carolinas Healthcare System
American College of Gastroenterology
Investigators
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
ClinicalTrials.gov Identifier: NCT01192698     History of Changes
Other Study ID Numbers: 04-05-09A
First Submitted: August 30, 2010
First Posted: September 1, 2010
Results First Submitted: August 1, 2014
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:
cirrhosis
hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents


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