Evaluation of Belatacept as First Line Immunosuppression in De Novo Liver Transplant Recipients

Criterios de inclusión

• Medical History and Concurrent Diseases
• First time recipient of deceased donor liver transplant
• Age 18-70
• Hepatitis C virus (HCV) positive recipients
• For Long-term extension study-Subjects who have completed one year of study treatment (through Week 52)
• Target Disease Exclusions:
• Donor Exclusions a) Living donors b) ABO-incompatible donor recipient pairs c) Donor age \< 12 or \> 65 years d) Non heart-beating donors e) Anticipated cold ischemia time \> 14 hours f) Donor Disease i) Known Human immunodeficiency virus (HIV) infection ii) Hepatitis B virus (HBV) surface antigen-positive or polymerase chain reaction (PCR)-positive donor if HBV negative recipient iii) HCV antibody-positive or PCR positive donor if HCV negative recipient
• Recipient Exclusions g) Subjects with a history of hypercoagulable state h) Subjects with fulminant hepatic failure i) Subjects receiving a split or reduced liver j) Subjects who are Epstein-Barr virus (EBV) negative
• Subjects who have received 2 or more consecutive weeks of dialysis 1 month prior to enrollment OR anticipated to have prolonged dialysis post-transplantation
• Subjects with known intrinsic renal disease (e.g., a urine protein/ creatinine ratio \> 150 mg/g or the presence of an abnormal number of red blood cells (RBCs) or granular casts in the urine) AND calculated GFR \< 40 ml/min/1.73 m\^2 body surface area (BSA) (abbreviated Modification of Diet in Renal Disease \[MDRD\]). Subjects must have a calculated GFR assessment within 1 month prior to enrollment.
• Subjects with known HIV
• Subjects with any prior or concurrent solid organ (e.g., heart, kidney, pancreas) or cell (e.g., islet, bone marrow) transplant or subjects deemed likely to have a second solid organ or cell transplant (e.g., islet, bone marrow) within the next 3 years.
• Subjects with a history of cancer within the last 5 years
• Allergies and Adverse Drug Reactions
• a) Hypersensitivity to any medications that will be used in the protocol
• Prohibited Treatments and/or Therapies
• Subjects receiving immunosuppressive agent(s) (e.g., methotrexate, abatacept, infliximab, etanercept, chemotherapy, etc.) within the past 6 months for other indications such as an autoimmune disease
• Subjects who received maintenance corticosteroids at a dose of \> 5 mg/day of prednisone (or equivalent) for at least 7 consecutive days within the prior year for an underlying chronic inflammatory or autoimmune disease
• Subjects who have used any investigational drug within 30 days prior to the Day 1 visit
• Subjects previously treated with belatacept