EUCTR2007-001361-15-IT进行中（未招募）不适用
An open-label, two-period, multi-center, single dose study to assess the pharmacokinetics of AEB071 in de novo liver transplant patients - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
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
- •Male and female patients of any race, 18 years or older Primary orthotopic liver transplant recipients. Allograft is functioning at an acceptable level by 24 hrs as determined by local investigator Recipients have been initiated on tacrolimus therapy (within 12 hours of transplantation). Females capable of becoming pregnant must have a negative pregnancy test within 7 days prior to enrollment. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria Recipients of prior organ transplants or patients recipients of multiple organ transplants (including combined liver- kidney transplantation). Recipients of ABO incompatible transplants. Recipients of living donor transplants or split liver transplants Transplant with a cold ischemic time of >12 hours. Transplants of donors after cardiac death (DCD). Patients with a MELD-score >35 during 1 month prior transplantation Transplant of a marginal graft into a patient with a MELD-score > 28 defined by any of the following criteria: donor age > 60, CIT > 10h, hypotension periods or inotropic support of the donor, stay on ICU > 3 days, graft steatosis > 30% Patients with acute, fulminant hepatic failure (UNOS I, T1) Patients who are anti-HIV-positive Patients with any past or present malignancy (other than excised basal cell carcinoma and hepatocellular carcinoma (HCC). Patients with a serum creatinine > 4.0 mg/dL or on dialysis Patients who received any investigational drug within 4 weeks prior to baseline or who are currently enrolled in a clinical trial. Patients who have received or are expected to receive induction antibody or any other immunosuppressive therapy not defined in the protocol. Patients who display hypersensitivity or contraindication to study drugs AEB071, tacrolimus or corticosteroids. Patients who are requiring the administration of strongly interacting drugs of the CYP450 3A4/5 system (see Appendix 5). Patients with active or a history of clinically significant cardiac abnormalities, such as: Left branch bundle block (LBBB), hospitalized in the previous 6 months for heart failure of cardiac etiology, significant and persistent left-ventricular dysfunction (LVEF < 40%), etc. Patients requiring drugs with QT-prolonging properties (e.g. antiarrhythmic drugs, such as amiodarone, sotalol, dofetilide, quinidine, procainamide, disopyramide)PLS SEE PROOCOL
研究者
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