Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C After Liver Transplantation (LADR)
Hepatitis C
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Ribavirin, PegInterferon alfa2b
Eligibility Criteria
Inclusion Criteria: Adult (18 or older) LDLT candidate HCV RNA positive Expected time on treatment is at least 12 weeks Candidates for DDLT who are listed for transplantation and meet UNOS criteria for MELD upgrade for HCC Exclusion Criteria: Severe cytopenia (polymorphonuclear (PMN) leukocytes < 750, OR hemoglobin [Hgb] < 10 g/dL, OR platelet count < 35,000/mm3) Uncontrolled depression or psychiatric disease characterized by current symptoms of major depression or other psychiatric disease or increase in medication for major depression or other psychiatric disease within the past three months. Uncontrolled cardiopulmonary disease characterized by myocardial infarction, coronary artery bypass graft surgery, Percutaneous coronary intervention, or unstable angina within the past three months. Uncontrolled autoimmune disease characterized by current symptoms of autoimmune disease or increase in medications within the last three months. Autoimmune hepatitis Active substance abuse within 6 months of initiation of treatment Known intolerance or serious adverse event during prior therapy with interferon or ribavirin Prior nonresponse after at least 24 weeks of full dose treatment with peginterferon plus ribavirin Laboratory Model for End-Stage Liver Disease (MELD) score >20. Patients with laboratory MELD score 21-25 may be enrolled if deemed appropriate by the site investigator Serum creatinine >2.2 mg/dL
Sites / Locations
- University of California Los Angeles
- University of California San Francisco
- University of Colorado
- Northwestern University Division of Transplantation
- Columbia University
- University of Pennsylvania Hospital
- University of Virginia
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
No Intervention
Experimental
LADR Treatment, Genotypes 1,4,6
Standard care
LADR treatment, Genotypes 2,3
Subjects randomized to low accelerating dose regimen (LADR) treatment
Subjects randomized to Standard Care group, Genotypes 1,4,6
Subjects randomized to low accelerating dose regimen (LADR) treatment.