Single Center, Open-label, Randomized, Controlled, Cross Over Study to Evaluate the Pharmacokinetic and Bioavailability of Envarsus® in Comparison to Advagraf® in de Novo Liver Transplant Recipients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- DAV (average cumulative dose) = cumulative dose per study period/ period days
研究概览
简要总结
Single centre, open-label, randomized, controlled, cross over study to evaluate the pharmacokinetic and bioavailability of Envarsus® in comparison to Advagraf® in de novo liver transplant recipients
详细描述
Using an open-label, randomized, controlled, 2-period cross-over design, two treatments (Envarsus® and Advagraf®) will be compared (with regard to PK profile and bioavailability) after administration of IMP to 20 de novo transplanted recipients. The patients will be randomly assigned to one of the two treatments as treatment period 1 and afterwards switched to treatment period 2 (Group 1: Envarsus® - Advagraf®; Group 2: Advagraf® - Envarsus®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand the patient information and to personally sign and date the informed consent to participate in the clinical trial, before completing any clinical trial related procedures.
- •Male or female recipients ≥ 18 years of a liver graft from a deceased or living donor
- •The patient must receive a twice daily Tacrolimus based immunosuppression treatment.
- •Females of child-bearing potential who agree to comply with any applicable contraceptive requirements of the protocol or females who are permanently sterilized (at least 6 weeks post sterilization).
- •Non-pregnant, non-lactating female.
- •Recipients of a first or re-liver transplant in the last 30 days
- •The patient is co-operative and available for the entire clinical trial.
排除标准
- •Patients with a known hypersensitivity to any of the drugs used in the study.
- •Patients who are not able to take oral medication at the time point of randomization.
- •Recipients of combined organ transplants.
- •Patients who are recipients of AB0 incompatible transplant grafts.
- •Currently participation in a clinical trial and any IMP intake within the last four weeks.
- •Patients who use drugs known to strongly interact with the cytochrome P-450 3A4 pathway and therefore influence the tacrolimus blood level are not allowed during Envarsus®/Advagraf® treatment period.
- •Patient with renal impairment with need of dialysis treatment at the time point of randomization.
- •Patient with a quick value < 30 %
- •Patient with a thrombocytopenia <20 Mrd./L
- •Patients with a leukopenia < 1.0 Mrd. / L
- •Patients with inability of oral food intake.
研究组 & 干预措施
Envarsus - Advagraf
干预措施: Treatment 2 weeks Envarsus followed by 2 weeks Advagraf (Drug)
Advagraf - Envarsus
干预措施: Treatment 2 weeks Advagraf followed by 2 weeks Envarsus (Drug)
结局指标
主要结局
DAV (average cumulative dose) = cumulative dose per study period/ period days
时间窗: 20 month
C0/doses (trough level at steady state / daily dose at steady state)
时间窗: 20 month
AUC0-24/doses
时间窗: 20 month
次要结局
未报告次要终点