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Evaluation of Belatacept as First Line Immunosuppression in De Novo Liver Transplant Recipients
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
Details
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 260 |
| Start date | 2008-01 |
| Completion | 2011-06 |
Conditions
- Immunosuppression in Solid Organ Transplant
Interventions
- Tacrolimus
- Basiliximab
- Belatacept More Intensive (MI)
- Belatacept Less Intensive (LI)
- Mycophenolate Mofetil (MMF)
Primary outcomes
- Percentage of Participants Who Experienced at Least One Episode of Acute Rejection (AR), Graft Loss, or Death by 6 Months Post-transplant — At 6 months posttransplant
Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a blinded central histopathologist using Banff grading schema. Graft loss was defined as impairment of liver function to such a degree that the participant died or underwent re-transplantation. For 95% (confidence interval) CI within each group, normal approximation is used if N\>=5, otherwise exact method is used. - Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) — Day 1 (randomization) to Week 104 + within 56 Days after the last infusion/dose, Deaths were monitored up to database lock (20-June-2011)
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. - Number of Participants Who Had AEs of Special Interest During the LTE — Day 1 (randomization) through database lock (20-June-2011)
AE of special interest included malignancies (including skin carcinomas), infections (viral, cytomegalovirus, herpes, fungal, and bacterial). - Number of Participants With Marked Hematology Abnormalities During the LTE — Every 4 weeks from Week 53 to Week 104.
Low platelet count: \<50\*10\^9 c/µl; Low leukocytes: \<2.0\*10\^3 c/µl; Low lymphocytes (absolute): \<0.5\*10\^3 c/µl; Low neutrophils (absolute): \<1.0\*10\^3 c/µl. - Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE — Every 4 weeks from Week 53 to Week 104.
ULN= upper limit of normal; Normal ranges are provided by the Central Laboratory and may vary according to sex and age. High alanine aminotransferase (ALT): \>5.0\*ULN U/L; High aspartate aminotransferase (AST): \>5.0\*ULN U/L; High direct bilirubin: \>3.0\*ULN mg/dL; High g-glutamyl transferase (GGT): \>5.0\*ULN U/L; High total bilirubin: \>3.0\*ULN mg/dL; High creatinine: \> 3.0\*ULN mg/dL - Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE — Every 4 weeks from Week 53 to Week 104.
Low Serum Potassium: \<3.0 meq/L; High serum potassium:\>6.0 mEq/L; Low serum magnesium:\<0.8 mEq/L; Low serum sodium: \<130 mEq/L; High serum sodium: \>155 mEq/L; Low inorganic phosphorus: \<2.0 mg/dL; High uric acid: \>10 mg/dL
Countries
United States, Argentina, Austria, Brazil, Canada, France, Germany, Italy, Spain