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NCT01192698 Clinical Trial

Intravenous Interferon During Liver Transplant

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01192698
Other study ID # 04-05-09A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2009
Est. completion date February 2013

Study information
Verified date July 2017
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - liver transplant for hepatitis c Exclusion Criteria: - allergy to interferon

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• IV interferon
IV interferon 5MU during anhepatic phase

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Wake Forest University Health Sciences American College of Gastroenterology

Outcome
Type Measure Description Time frame Safety issue
Primary HCV RNA Result Will measure mean HCV RNA levels 4 weeks after liver transplant 4 weeks after liver transplant
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