Civicir

Overview

Status: Recruiting
Keywords: Liver Transplantation , Hepatitis C
IRB Number: 00064205
Specialty: Transplant Surgery
Sub Specialties: Liver Transplant

Brief Summary

To determine efficacy, safety and PK of HCIG in liver transplanted patients. To attain unquantifiable levels of hepatitis C virus RNA (lower limit of quantitation (LLOQ) <43 IU/mL) at 12 weeks after orthotopic liver transplantation with an observation period of an additional 12 weeks after transplantation for durability of effect.

Principal Investigator: Jeffrey Campsen
Department: General Surgery
Co Investigator: Robin Kim
Co Investigator: Juan Gallegos-Orozco

Contact Information

Name:Heather Thiesset
Phone: 801-585-3098
Email: heather.thiesset@hsc.utah.edu

Inclusion Criteria

HCV genotype 1-6 infection. Subjects treated with antiviral therapy for up to and including 24 weeks prior to OLT. Most recent evidence within the last 4 weeks that HCV RNA is <100 IU/mL. Male and female subjects (age 18-70 years). Subject weight under 250lbs. Stable patient in a condition which in the opinion of the investigator would permit safe participation in the study.

Exclusion Criteria

Re-transplant due to viral recurrence. Positive HIV or HBV test at time of transplant. Most recent PCR test indicating HCV RNA > 100 IU/mL within 4 weeks of OLT. Subjects having received organs from HCV positive donors. Serum creatinine level >2.5 times the upper limit of normal or advanced renal disease at screening. Pregnancy or single contraceptive measure or lactation period (females only). Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction). Known absolute IgA deficiency. Known intolerance to proteins of human origin. Participation in another clinical trial within 90 days before signing informed consent. Active drug or alcohol abuse.