EUCTR2007-002125-68-DE进行中（未招募）不适用
Evaluation of Belatacept as First-line Immunosuppression in De Novo Liver Transplant Recipients Revised Protocol Number 04, incorporating Amendments 02, 03, 04 and 05 (version 10.0 dated 20-Nov-09)+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific, version 2.0 dated 20-Jul-07
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 275
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Signed Written Informed Consent
- •a) The subject is willing to provide signed written informed consent
- •2) Target Population
- •a) The subject is a first-time recipient of a deceased donor liver transplant
- •3) Age and Sex
- •a) Men and women, ages 18 to 70 years, inclusive
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 56 days after the last dose of investigational product in such a manner that the risk of pregnancy is minimized.
- •WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as:
- •Amenorrhea = 12 consecutive months without another cause or
- •For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level = 35 mIU/mL.
- •Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential.
- •Women of child bearing potential taking MMF should be advised that per the US product information, two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method.
- •WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product.
- •Long-Term Extension (Protocol Amendment 3):
- •1) Signed Written Informed Consent
- •2) Target Population
- •a) The subject has completed 1 year of study treatment (through Week 52)
- •b) The subject is willing and able to continue therapy with their original assigned
- •study medication (belatacept or tacrolimus)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Sex and Reproductive Status
- •a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 56 days after the last dose of investigational product.
- •b) Women who are pregnant or breastfeeding
- •c) Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- •2) 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 HIV infection
- •ii) HBV surface antigen-positive or 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 EBV negative
- •3) Medical History and Concurrent Diseases
- •a) Subjects who have received 2 or more consecutive weeks of dialysis 1 month prior to enrollment OR anticipated to have prolonged dialysis post-transplantation
- •b) Subjects with known intrinsic renal disease (e.g., a urine protein/ creatinine ratio > 150 mg/g or the presence of an abnormal number of RBCs or granular casts in the urine) AND calculated GFR < 40 ml/min/1.73 m2 BSA (abbreviated MDRD). Subjects must have a calculated GFR assessment within 1 month prior to enrollment.
- •c) Subjects with known HIV
- •d) Subjects with any prior or concurrent solid organ or cell transplant or subjects deemed likely to have a second solid organ or cell transplant (e.g., islet, bone marrow) within the next 3 years.
- •e) Subjects with a history of cancer within the last 5 years
- •Exceptions:
- •i) Subjects with hepatocellular carcinoma may be enrolled if they meet the Milan Criteria: a single nodule = 5 cm in diameter or up to 3 nodules with none > 3 cm in diameter
- •ii) Non-melanoma skin cancers cured by local resection
- •f) Subjects at risk for tuberculosis (TB). Specifically, subjects:
- •i) With current clinical, radiographic, or laboratory evidence of active or latent TB as determined by local standard of care.
- •ii) With history of active TB:
- •(1) Within the last 2 years, even if it was treated
- •(2) Greater than 2 years ago, unless there is documentation of adequate treatment according to locally accepted clinical practice
- •iii) Who, in the opinion of the investigator and based upon appropriate evaluation, have a risk of reactivation of TB that precludes administration of conventional immunosuppression
- •g) Subjects with any active infection or other contraindication that would normally exclude transplantation
- •h) Subjects with active peptic ulcer disease, chronic diarrhea, or gastrointestinal malabsorption
- •4) Physical and Laboratory Test Findings
- •a) Subjects with laboratory values that meet the following criteria are to be excluded from the study:
- •i) Hemoglobin < 7 g/dL
- •ii) White blood cell (WBC) count < 2000/mm³ (2 x 109/L)
- •b) Subjects who have difficult intravenous access or other reasons that would likely preclude the ability to receive long-term intravenous infusions.
- •c) Subjects with a chest radiograph consistent with an acute lung parenchymal process or malignancy. Subjects must have a chest radiograph no more than two months prior to enrollment.
- •d) Subjects with a mammogram that is suspicious for malignancy. All women 50 years or o
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