Status:
COMPLETED
Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant
Lead Sponsor:
University Hospital, Geneva
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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.
Detailed Description
The aim of the study is to assess whether patients fulfilling the criteria as defined in section 3 will benefit from a treatment with ribavirin/PEG-a-IFN combined treatment. This study will be open to...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00466219
Start Date
May 1 2002
End Date
December 1 2006
Last Update
April 27 2007
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