Belatacept in Liver Transplant Recipients

Stopped early · Phase 2

Conditions studied: Immunosuppression in Solid Organ Transplant

In brief

The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant

Key facts

Study ID

NCT00555321

Run by

Bristol-Myers Squibb

People needed

260

Starts

2008-01-01

Expected to finish

2011-06-01

Last updated by the study team

2012-10-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Medical History and Concurrent Diseases
• 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

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Usc University Hospital — Los Angeles, California, United States
• University Of California San Francisco Medical Center — San Francisco, California, United States
• Mayo Clinic Transplant Department — Jacksonville, Florida, United States
• Lifelink Healthcare Institute — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northwestern University Feinberg School Of Medicine — Chicago, Illinois, United States
• Tulane Center For Abdominal Transplant — New Orleans, Louisiana, United States
• Henry Ford Hospital — Detriot, Michigan, United States
• University Of Minnesota — Minneapolis, Minnesota, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• Nyu School Of Medicine — New York, New York, United States
• Westchester Medical Center — Valhalla, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Univ. Of Cin. Coll. Of Med. — Cincinnati, Ohio, United States
• Integris-Baptist Medical Ctr. — Oklahoma City, Oklahoma, United States
• Hospital Of The University Of Pennsylvania — Philadelphia, Pennsylvania, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Froedtert Memorial Lutheran Hospital — Milwaukee, Wisconsin, United States
• Local Institution — Ciudad de Buenos Aires, Buenos Aires, Argentina
• Local Institution — Vienna, Austria
• Local Institution — Curitiba, Paraná, Brazil
• Local Institution — Rio de Janeiro, Rio de Janeiro, Brazil
• Local Institution — Centro-Porto Alegre, Rio Grande do Sul, Brazil
• Local Institution — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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