Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to assess whether patients with recurrent hepatitis C after liver transplantation will benefit from a treatment with ribavirin/PEG-IFN-alpha combined treatment for 48 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Geneva
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• 18 to 65 year old patients, male or female, having undergone a LT for end-stage liver disease due to HCV

• patients presenting after LT with recurrent HCV infection, documented by presence of HCV RNA in serum, and recurrent hepatitis, diagnosed at histology; the liver biopsy upon which the diagnosis is established must have been performed within the 12 months prior to inclusion; the treatment cannot start within the 6 months following LT

• alpha fetoprotein value within normal limits obtained within 3 months before entry visit

• stable immunosuppressive regimen, defined as lack of any therapeutic measures aimed at preventing or treating graft rejection during the three months prior to antiviral therapy

Exclusion Criteria:

• participation in other clinical trial within 30 days of entry into this protocol

• patients retransplanted for rejection or for recurrent hepatitis C on the graft

• patients with a history of cardiovascular disease including but not limited to uncontrolled hypertension, angina pectoris, myocardial infarction, coronary artery surgery and congestive heart failure are excluded

• presence of HBsAg and/or HIV

• history of auto-immune disease, including auto-immune hepatitis

• alcohol consumption exceeding 40 grams per day

• acute rejection episode within the 3 months prior to inclusion, or current histological features possibly related to underlying rejection

• hepatocellular carcinoma

• unresolved biliary complication

• renal insufficiency (serum creatinine levels above 200 micromol/l)

• unconjugated bilirubin blood level > 100 micromol/l

• gammaglutamyl transferase > 20 times the upper limit of normal range

• prothrombin time below 60% of control (except in case of oral anti-coagulant therapy)

• neutrophil count less than 1,500/mm3

• platelet count less than 90,000/mm3

• hemoglobin below the lower limit of normal of the testing laboratory

• other organ or bone marrow transplantation

• current neoplasm and/or anti-tumor chemotherapy

• current hepatic arterial thrombosis

• pregnant or breast feeding women; child bearing potential women without adequate contraception throughout the course of therapy

• psychosis or anti-depressant therapy for uncontrolled clinical depression

• clinically significant retinal abnormalities

• thyroid dysfunction (abnormal TSH value with or without clinical symptoms)

• immunosuppressive therapy with OKT3 or any other anti-lymphocyte serum

• drug abuse (heroin, cocaine) or substitution therapy during the 12 months prior to inclusion

• history of ischemic cardiopathy

• interstitial pneumonitis

• previous auto-immune hemolysis and all causes of chronic hemolysis