EUCTR2015-001041-83-Outside-EU/EEA进行中（未招募）不适用
Clinical and Laboratory Evaluation of Acute Rejection, Myocyte Growth, Repair, and Oxidative Stress Following de novo Cardiac Transplant: A Comparison between Tacrolimus- and Cyclosporine- based Immunoprophylactic Regimens with Mycophenolic AcidTherapeutic Drug Monitoring
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
- 100
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. Patients (or their legal guardians) who are capable of understanding, and who have been fully informed of, the purpose of the study and the risks of participation.
- •2. Patients (or their legal guardians) who have signed and dated the Informed Consent Form and are willing and able to follow the study protocol.
- •3. Patients who are primary cadaveric heart transplant recipients.
- •4. Males or females from birth.
- •5. Female patients of child-bearing potential who have a current negative pregnancy test and agree to practice effective birth control, as judged by the investigator, while participating in the study. Prepubescent pediatric patients will not require pregnancy testing.
- •6. Patients able to tolerate oral medication and who do not have a gastrointestinal condition likely to affect the absorption kinetics or metabolism of the oral study medications.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Previous organ transplant recipients.
- •2. Multi-organ transplant recipients.
- •3. Recipients of a heart from a donor with incompatible ABO blood type.
- •4. Patients with significant graft dysfunction and/or significant de novo infection(s) at time of randomization (i.e. within 10 days of transplantation).
- •5. Patients with known hypersensitivity to tacrolimus, cyclosporine, mycophenolate mofetil, daclizumab, prednisone, cremophor, polysorbate 80 and/or HCO-60.
- •6. Patients who are pregnant or lactating or planning to become pregnant prior to completion of the study.
- •7. Patients who have consumed an investigational (i.e. unmarketed) product in the 30 days prior to transplantation or at any time during posttransplantation follow-up.
- •8. Patients receiving cholestyramine or colestipol.
- •9. Patients having any one of the following at enrolment:
- •a. History of malignancy which is not currently chart-documented as cured or active malignancy (with exception of eradicable nonmetastatic in-situ basal cell or squamous cell carcinoma of the skin).
- •b. Leukopenia (white cell count < 2500/cu mm).
- •c. Anemia (hemoglobin < 80 g/L).
- •d. Positive test for Hepatitis B surface antigen and/or Hepatitis C.
- •e. Historical positive test for Human Immunodeficiency Virus (HIV).
- •f. Serum creatinine > 230 µmol/l.
- •g. Continual elevation of AST and/or ALT to = 3X the upper limit of normal.
- •h. Body mass index (weight in kg / height in m2) > 30.
- •10.Undiagnosed diabetes mellitus as determined by 2h OGTT or fasting glucose test or uncontrolled diabetes mellitus at screening. In either case, the patient may be declared as no longer excluded by this criterion upon establishment of control of the diabetes through appropriate medical management.
- •11.Blood glucose = 11.1 mmol/L at pre-operative assessment.
- •12.Patients having a significant disease, substance dependency, or disability that may prevent adherence to, or understanding of, the protocol and/or the investigator’s instructions.
研究者
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