EUCTR2007-001821-85-GB进行中（未招募）1 期
A 24 month, multi-center, open-label, randomized, controlled study to evaluate the efficacy and safety of concentration controlled everolimus to eliminate or to reduce tacrolimus compared to tacrolimus in de novo liver transplant recipients.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •Ability and willingness to provide written informed consent and adhere to study regimen.
- •Recipients who are 18-70 years of age of a primary liver transplant from a deceased donor.
- •Allograft is functioning at an acceptable level by the time of randomization as defined by the AST, ALT, Total Bilirubin levels =3 times ULN, and AlkP and GGT levels = 5 times ULN. Elevated GGT alone, in combination with AST, ALT, total bilirubin and AlkP within the defined range does not exclude patients from randomization.
- •Recipients who have been initiated on an immunosuppressive regimen that contains corticosteroids and tacrolimus, 3-7 days post-transplantation.
- •Confirmed recipient HCV status at Screening (either by serology or by PCR).
- •Abbreviated MDRD eGFR = 30 mL/min/1.73m2. Local and central serum creatinine
- •results obtained within 5 days prior to randomization are acceptable, however no sooner than Day 25 post-transplantation.
- •Verification of at least one tacrolimus trough level of = 8 ng/mL in the week prior to
- •randomization. Investigators should make adjustments in tacrolimus dosing to continue to target trough levels above 8 ng/mL prior to randomization.
- •Patients who are able to take oral medication at time of randomization.
- •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
- •Patients who are recipients of multiple solid organ or islet cell tissue transplants, or have previously received an organ or tissue transplant. Patients who have a combined liver-kidney transplant.
- •Recipients of a liver from a living donor, or of a split liver.
- •History of malignancy of any organ system within the past 5 years whether or not there is evidence of local recurrence or metastases, other than non-metastatic basal or squamous cell carcinoma of the skin, or HCC (see next criteria).
- •Hepatocellular carcinoma that does not fulfill Milan criteria at the time of transplantation as per explant histology of the recipient liver.
- •Any use of antibody induction therapy.
- •Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients
- •Patients who are recipients of ABO incompatible transplant grafts.
- •Recipients of organs from donors who test positive for Hepatitis B surface antigen or HIV are excluded.
- •Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study drug.
- •Women of child-bearing potential (WOCBP), defined as all women physiologically
- •capable of becoming pregnant, including women whose career, lifestyle, or sexual
- •orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS (1) they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m, or (2) have past 6 weeks from surgical bilateral oophorectomy with or without hysterectomy or (3) are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), copper coated IUD and double-barrier methods ( any double combination of male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should bemaintained throughout the and for 3 months after study drug discontinuation.
- •Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation which would preclude liver biopsy after transplantation. (Low dose aspirin treatment or interruption of chronic anticoagulant is allowed).
- •Patients with a confirmed spot urine protein/creatinine ratio that indicates = 1.0 g/24 hrs of proteinuria at baseline and that cannot be explained by immediate post operative effects.
- •Use of immunosuppressive agents or treatments after baseline that are not utilized in the protocol.
- •Patients who have severe hypercholesterolemia (>350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L) within 6 months of transplantation. Patients with controlled hyperlipidemia are acceptable at the time of randomization.
- •Patients with platelet count < 50,000/mm3 at the time of randomization.
- •Patients with an absolute neutrophil
研究者
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