EUCTR2005-003413-32-GB进行中（未招募）不适用
A 24-month, multicenter, randomized, open-label non-inferiority study of efficacy and safety comparing two exposures of concentration-controlled Certican with reduced Neoral versus 3.0g MMF with standard dose Neoral in de novo heart transplant recipients. -
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
- 590
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 or female cardiac recipients 18-70 years of age undergoing primary heart
- •transplantation. The graft must be functional at the time of randomization.
- •Patients who have given written informed consent to participate in the study.
- •Women of childbearing potential should have a negative serum or urine pregnancy
- •test with a sensitivity of at least 25 mIU/mL within 1 week prior to beginning
- •therapy. Females are eligible if they are postmenopausal for at least 24 months past
- •last natural menses. Study medication should not be administered until a negative
- •pregnancy test report is obtained. Two or more acceptable methods of contraception
- •should be started 1 month prior to beginning study drug unless abstinence is the
- •chosen method, during therapy, and for 3 months after stopping the study.
- •Abstinence is an allowed contraceptive method if in the judgment of the investigatorthe patient is reliably abstaining. Celibate members of religious orders (like nuns,
- •priests, etc...) will be considered in consultation with the local Novartis Medical
- •Advisor on a case by case basis. Although there may be local/ country specific
- •differences, acceptable forms of birth control include any two or more of the
- •following methods: surgical sterilization (e.g. bilateral tubal ligation, hysterectomy),
- •hormonal contraception (implantable, patch, oral), IUD and barrier methods (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.
- •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
- •Calculated creatinine clearance < 40 mL/min at screening (using MDRD formula).
- •Patients with platelet count < 50,000/mm3 at the evaluation before randomization.
- •Patients who are recipients of multiple solid organ or tissue transplants or have previously received organ transplants.
- •Patients who are recipients of ABO incompatible transplants.
- •Patients with clinically significant systemic infection at the time of transplant or within two weeks prior to transplant.
- •Patients who received any investigational drug or who have been treated with a non-protocol immunosuppressive drug or treatment within 1 month prior to randomization.
- •Patients receiving induction therapy in non induction center.
- •Patients not receiving induction Simulect.
- •Induction therapy other than Simulect or thymoglobulin
- •Patients at a Simulect induction therapy site recieving an induction therapy that is not Simulect or a patient in a Thymoglobulin induction site receiving induction therapy other than Thymoglobulin.
- •Presence of severe hypercholesterolemia (= 350 mg/dL; = 9 mmol/L) or
- •hypertriglyceridemia (= 750 mg/dL; = 8.5 mmol/L) before randomization.
- •Patients with an absolute neutrophil count of = 1,500/mm3 or white blood cell count of = 4000/mm3 at baseline before surgery.
- •Patients with a history of significant coagulopathy or medical condition requiring long term anti-coagulation after transplantation (low dose aspirin treatment is allowed).
- •Patients who have tested positive for HIV, or Hepatitis C or are positive for Hepatitis B surface antigen.
- •Laboratory results obtained within 6 months prior to study entry are acceptable; otherwise these tests should be performed within one week after randomization
- •Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded.
- •Patients being treated with terfenadine, astemizole, or cisapride.
- •Patients with any past history (within the past 5 years) or present malignancy, whether or not there is evidence of local recurrence or metatases (other than excised non- melanoma skin lesions).
- •Patients with a known hypersensitivity to similar drugs and to the components of the formulations.
- •Patients with donor greater than 65 years and/or with known donor coronary or heart disease at the time of transplant.
- •Donor heart cold ischemic time > 6 hours.
- •Patients who are treated with drugs strong inducers or inhibitors of cytochrome P450 3A4. (See appendix 4).
- •Patients who are unable to take oral medication by mouth (short- term NG administration allowed no longer than Day 5).
- •Existence of any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication, and/or the presence of severe diarrhea or active peptic ulcer.
- •Abnormal physical or laboratory findings of clinical significance within 2 weeks of
- •randomization which would interfere with the objectives of the study.
- •Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use at least 2 effective means of contraception.
研究者
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