EUCTR2005-003413-32-BE进行中（未招募）1 期
A 24-month, multi-center, randomized, open-label non-inferiority study of efficacy and safety comparing two exposures of concentration-controlled Certican with reduced Neoral versus 3.0 g MMF with standard dose Neoral in de novo heart transplant recipients.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 630
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.
- •Patients who have given written informed consent to participate in the study.
- •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 (MDRD Formula)
- •Patients with platelet count <50,000/mm at the evaluation before randomization.
- •Patients who are recipients of multiple solid organ transplants.
- •Patients who are recipients of ABO incompatible transplants
- •Patients with active systemic infection.
- •Patients receiving drugs used for non-approved indications in the 30 days prior to study entry.
- •Patients receiving induction therapy in non induction center
- •Patients not receiving induction therapy in an induction center
- •Induction therapy other than Simulect
- •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 are HIV-positive or Hepatitis C (PCR+ only) or B surface antigen positive. Laboratory results obtained within 6 months prior to study entry are acceptable.
- •Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C (PCR+ only) are excluded
- •Patients being treated with terfenadine, astemoizole, or cisapride
- •Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma)
- •Patients with a known hypersensitivity to drugs of this class.
- •Patients with donor greater than 65 years and/or with known donor heart disease at the time of transplant.
- •Patients who are treated with drugs strong inducers or inhibitors of cytochrome P450 3A4.
- •Cold ischemia time >6 hours.
- •Unable to take oral medication.
研究者
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