跳至主要内容
临床试验/NCT00149981
NCT00149981No Longer Available不适用

A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家开始时间: 2005年9月8日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
No Longer Available
试验地点
1

研究概览

简要总结

Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties

详细描述

This is a treatment protocol designed only to provide access to everolimus (RAD) for maintenance immunosuppression. The objectives are to facilitate the management of patients on maintenance immunosuppression therapy who are completing everolimus trials,

  • To provide everolimus maintenance therapy through this access program and
  • To collect and review safety data for up to 120 months or until the project has been discontinued whichever comes first.
  • To collect and review safety data for up to 120 months or when Certican is commercially available in the given indication and reimbursed by appropriate payors or the project has been discontinued whichever comes first.

研究设计

研究类型
Expanded Access

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female recipients of solid organ transplants
  • Subject is currently enrolled in an everolimus (RAD) trial sponsored by Novartis
  • Currently on investigational drug everolimus (RAD) therapy

排除标准

  • Inability or unwillingness to comply with immunosuppressive regimen.
  • Pregnancy.
  • History of acute organ rejection within the last 3 months.
  • Other protocol-defined inclusion/exclusion criteria may apply.

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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