Intravenous Interferon During Liver Transplant

Not Applicable

Completed

• Conditions: Hepatitis C; Cirrhosis
• Interventions: Drug: IV interferon

• Registration Number: NCT01192698
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-08-31
• Study First Posted: 2010-09-01
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2014-08-01
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-31
• Results First Posted: 2017-08-07
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• liver transplant for hepatitis c

Exclusion Criteria

• allergy to interferon

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV interferon	IV interferon	IV interferon oral ribavirin

Primary Outcome Measures

Name	Time	Method
HCV RNA Result	4 weeks after liver transplant	Will measure mean HCV RNA levels 4 weeks after liver transplant