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Intravenous Interferon During Liver Transplant

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01192698
Enrollment
15
Registered
2010-09-01
Start date
2009-10-31
Completion date
2013-02-28
Last updated
2022-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Hepatitis C

Keywords

cirrhosis, hepatitis C

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.

Interventions

DRUGIV interferon

IV interferon 5MU during anhepatic phase

Sponsors

American College of Gastroenterology
CollaboratorOTHER
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* liver transplant for hepatitis c

Exclusion criteria

* allergy to interferon

Design outcomes

Primary

MeasureTime frameDescription
HCV RNA Result4 weeks after liver transplantWill measure mean HCV RNA levels 4 weeks after liver transplant

Participant flow

Participants by arm

ArmCount
IV Interferon
IV interferon oral ribavirin Aims The purpose of this study was to determine the safety and effect of intravenous interferon (IFN) during the anhepatic phase of LT on hepatitis C viral load. Methods Fifteen consecutive subjects undergoing liver transplant for hepatitis C cirrhosis were enrolled in the study, ten of which received study drug and five subjects served as controls. Cases received weight-based ribavirin and subcutaneous IFN at time of incision followed by intravenous IFN at the start of the anhepatic phase.
10
no Treatment
standard of care for liver transplant
5
Total15

Baseline characteristics

Characteristicno TreatmentIV InterferonTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
5 Participants10 Participants15 Participants
Age, Continuous55.8 years57 years56.4 years
Region of Enrollment
United States
5 participants10 participants15 participants
Sex: Female, Male
Female
1 Participants0 Participants1 Participants
Sex: Female, Male
Male
4 Participants10 Participants14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
1 / 100 / 5
serious
Total, serious adverse events
3 / 100 / 5

Outcome results

Primary

HCV RNA Result

Will measure mean HCV RNA levels 4 weeks after liver transplant

Time frame: 4 weeks after liver transplant

ArmMeasureValue (MEAN)
IV InterferonHCV RNA Result924,082 IU/ml
no TreatmentHCV RNA Result3,731,749 IU/ml

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026