NL-OMON37034已完成2 期
An extension to a 12-month, open-label, randomised, multicenter, sequential cohort, dose finding study to evaluate the efficacy, safety and tolerability of oral AEB071 versus Neoral® in combination with Certican®, Simulect® and corticosteroids in de novo adult renal transplant recipients - CAEB071A2206-E1
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •The patient has given written informed consent to participate in the extension study.
- •The patient has been maintained on AEB071/Certican® or Neoral®/Certican®, consistent with their original randomisation, at their core study Month 12 visit.
- •Women capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s).
排除标准
- •Inability or unwillingness to comply with the immunosuppressive regimen or the protocol.
- •Pregnancy.
研究者
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