Back to resultsIntravenous Interferon During Liver Transplant
Primary Purpose
Hepatitis C, Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IV interferon
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring cirrhosis, hepatitis C
Eligibility Criteria
Inclusion Criteria:
- liver transplant for hepatitis c
Exclusion Criteria:
- allergy to interferon
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
IV interferon
Standard of care
Arm Description
IV interferon oral ribavirin
standard of care
Outcomes
Primary Outcome Measures
HCV RNA Result
Will measure mean HCV RNA levels 4 weeks after liver transplant
Secondary Outcome Measures
Full Information
NCT ID
NCT01192698
First Posted
August 30, 2010
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
American College of Gastroenterology
1. Study Identification
Unique Protocol Identification Number
NCT01192698
Brief Title
Intravenous Interferon During Liver Transplant
Official Title
Intravenous Interferon During the Anhepatic Phase of Liver Transplantation and Prevention of Recurrence of Hepatitis C Virus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
American College of Gastroenterology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Cirrhosis
Keywords
cirrhosis, hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV interferon
Arm Type
Experimental
Arm Description
IV interferon oral ribavirin
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
standard of care
Intervention Type
Drug
Intervention Name(s)
IV interferon
Intervention Description
IV interferon 5MU during anhepatic phase
Primary Outcome Measure Information:
Title
HCV RNA Result
Description
Will measure mean HCV RNA levels 4 weeks after liver transplant
Time Frame
4 weeks after liver transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
liver transplant for hepatitis c
Exclusion Criteria:
allergy to interferon
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark W Russo, MD, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intravenous Interferon During Liver Transplant
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