effects of pegylated interferon alfa-2b and ribavirin after orthotopic liver transplantation in subjects with chronic hepatitis c recurrence (p04590am3)(completed)

Conditions: Liver Transplantation; Hepatitis C, Chronic; Liver Cirrhosis

Summary: this is an exploratory study and is a phase 3, single-arm, multi-center, open-label study of pegylated interferon alfa-2b, peg-ifn alpha-2b (peg-intron) and ribavirin (rbv) to determine the sustained virologic response (svr) at 24-week follow-up to 48 week in subjects after orthotopic liver transplantation (olt) with chronic hepatitis c (hcv) recurrence.


Eligibility criteria:
inclusion criteria: * subjects must confirm that all prior medication washout times have been observed. * subject must be 18 - 70 years of age of either gender and of any race. * subject must be transplanted for end-stage hepatitis c or fulminant hepatitis c. * subject must have documented: * persistent hcv viremia after olt as defined by plasma positive for hcv rna by quantitative reverse transcription-polymerase chain reaction (rt-pcr), * a liver transplant performed at least 3 months prior to screening but not more than 3 years prior to screening. * subject must be on stable doses of immunosuppression for at least 1 month. * compensated liver disease with minimum hematologic, biochemical, and serologic criteria at the (day 1) baseline visit. * alpha-fetoprotein value (afp) less than or equal to 250ng/ml. if afp greater than 100 ng/ml, patient will need evidence of normal liver (magnetic resonance imaging) mri and normal chest computerized tomography (ct) scan within the last 3 months or during the screening period. * for subjects with a history of diabetes or hypertension, clearance from an ophthalmologist has to be obtained prior to treatment start (day 1/visit 2). * subjects with a history of mild depression may be considered for entry into this study. * female subjects cannot be pregnant or breastfeeding and must be either postmenopausal, surgically sterile or using 2 methods of birth control. * sexually active male subjects are practicing an acceptable, method of contraception. * contraceptive measures will be reviewed with female subjects at each visit. dual methods of contraception must be used for 1 month prior to the start of treatment and 6 months after treatment discontinuation. * pregnancy tests obtained at screen visit and day 1 visit prior to the initiation of treatment must be negative. exclusion criteria: * pregnant women, women who plan to become pregnant, male subjects whose partner wants to become pregnant, and breastfeeding women (during study and up to 6 months after study completion). * subject has used any investigational product within 30 days prior to screening or is participating in any other clinical study. * prior treatment for chronic hepatitis c post-liver transplant, including but not limited to antiviral or immunomodulatory product, any interferon product, or rbv, either as monotherapy or in combination. * subjects with other organ transplants. * any subject who received a positive hepatitis c core antibody (hbcab) or hcv positive donor liver graft. * retransplantation of the liver for rejection or graft failure. * evidence of decompensated liver disease. * known coagulopathies including hemophilia. * known hemoglobinopathies. * known glucose-6-phosphate dehydrogenase (g6pd) deficiency. * hypersensitivity to alpha interferon and/or rbv. * co-infection with hepatitis b virus (hbv) and/or human immunodeficiency virus (hiv). * evidence of active or suspected malignancy or a history of malignancy within the last 5 years (with the exception of pre-transplant hepatocellular carcinoma histologically within the milan criteria, and adequately treated basal or squamous cell carcinoma of the skin). * any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study. * subject is or was a substance abuser. subjects treated with buprenorphine (subutex) who have been stable for 6 months may be included. * patients weighing over 135 kg; is participating in any other clinical study(ies); is allergic to or has sensitivity to the study drug or its excipients.