The objective of this study is to study the impact of prophylactic administration of antiviral therapy (Prophylaxis Arm) as compared to initiation of antiviral therapy at the time of clinical recurrence of Hepatitis C infection (Observation Arm). Another primary objective is to compare the efficacy, tolerability and safety of antiviral therapy in posttransplant patients in the two arms.

Condition	Treatment or Intervention	Phase
Hepatitis C	Drug: Pegylated Interferon alfa-2a in combination with Ribavirin	Phase IV

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Positive Hepatitis C RNA at pre-liver transplantation
• Age >= 18 years
• Primary, single organ recipient (cadaveric donor)
• Negative pregnancy test for women
• Normal TSH
• Liver transplant >= 10 weeks and <= 16 weeks before treatment initiation (Observation arm)
• Patients with pre-OLT diagnosis of hepatocellular carcinoma (HCC) as long as there is no evidence of extrahepatic spread, tumor is solitary and <5 cm or there are up to 3 tumors each <3 cm.

Exclusion Criteria:

• Multi-organ or retransplant recipient
• Patients with HCC who do not meet the inclusion criteria or require systemic chemotherapy
• Recipient of ABO incompatible organ
• Donor cold ischemia time >20 hours
• Anti-HBc +ve donor
• Histological evidence of unresolved rejection
• Episode of steroid resistant rejection / use of OKT3
• Evidence of current Hepatitis B
• Seropositivity for HIV infection
• Serum creatinine >2x upper limit of normal
• White blood cells >20,000 x 10^9 or ANC <1,500 cells/mm^3
• Hb <10 g/dl and/or platelets <50,000/mm^3
• History of autoimmune disease (SLE, scleroderma, rheumatoid arthritis, etc.)
• Uncontrolled seizure disorder
• Uncontrolled depression or history of suicide attempts/ideation
• History or evidence of retinopathy
• Unable or unwilling to give informed consent

Please reference Study ID Number: RLI-ML18124      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

Alabama
      Birmingham,  Alabama,  35294,  United States; Not yet recruiting
Arizona
      Phoenix,  Arizona,  85054,  United States; Recruiting
California
      San Francisco,  California,  94143,  United States; Recruiting
      San Francisco,  California,  07110,  United States; Recruiting
      Los Angeles,  California,  90095,  United States; Recruiting
Colorado
      Denver,  Colorado,  80262,  United States; Recruiting
Florida
      Gainesville,  Florida,  32611,  United States; Recruiting
      Coral Gables,  Florida,  33124,  United States; Not yet recruiting
      Jacksonville,  Florida,  32224,  United States; Recruiting
Illinois
      Evanston,  Illinois,  60208,  United States; Recruiting
Indiana
      Indianapolis,  Indiana,  46202,  United States; Recruiting
Maryland
      Baltimore,  Maryland,  21205,  United States; Recruiting
Massachusetts
      Burlington,  Massachusetts,  01805,  United States; Recruiting
Minnesota
      Rochester,  Minnesota,  55905,  United States; Recruiting
      Minneapolis,  Minnesota,  55455,  United States; Recruiting
Missouri
      St. Louis,  Missouri,  63110,  United States; Recruiting
Nebraska
      Omaha,  Nebraska,  68198,  United States; Recruiting
New York
      New York,  New York,  10016,  United States; Recruiting
      New York,  New York,  10029,  United States; Recruiting
Pennsylvania
      Philadelphia,  Pennsylvania,  19141,  United States; Recruiting
      Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Texas
      Dallas,  Texas,  75204,  United States; Recruiting
Washington
      Seattle,  Washington,  98195,  United States; Recruiting
Wisconsin
      Madison,  Wisconsin,  53706,  United States; Recruiting

Study ID Numbers:  ML18124
Record last reviewed:  April 2005
Last Updated:  April 6, 2005
Record first received:  July 12, 2004
ClinicalTrials.gov Identifier:  NCT00087633
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08