NCT00037531已完成3 期
An Open-label Extension Study of the Safety of Long-term Administration of Sirolimus (Rapamune™) in Solid Organ Transplant Recipients
Wyeth is now a wholly owned subsidiary of Pfizer20 个研究点 分布在 2 个国家目标入组 769 人开始时间: 2002年5月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 769
- 试验地点
- 20
研究概览
简要总结
To evaluate the safety of long-term administration of sirolimus oral solution for up to 5 additional years, or until the tablet formulation is commercially available (whichever occurs first) in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus (with or without cyclosporine (CsA). To evaluate the pharmacokinetics and safety of long-term administration of sirolimus tablets administered for up to 5 years, or until the tablet formulation is commercially available in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus (with or without CsA) or who are currently enrolled in protocol 0468E1-306-US.
研究设计
- 研究类型
- Interventional
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
- •Completion of sirolimus/blinded therapy in solid organ clinical trials (with or without CsA) with satisfactory compliance and an adequate safety profile.
- •Women of childbearing potential who have a negative pregnancy test before enrollment into this study and who agree to practice either a hormonal or barrier method of birth control throughout the treatment period and for 3 months following discontinuation of sirolimus may be enrolled into the study.
- •Signed and dated informed consent
排除标准
- •Unstable disease states, which in the opinion of the investigator would present a risk to the patient.
- •Known hypersensitivity to macrolide antibiotics
研究者
研究点 (20)
Loading locations...
相似试验
终止
3 期
Open-label Extension for Phase 3 Clinical Trials of SimufilamAlzheimer DiseaseNCT05575076Cassava Sciences, Inc.1,081
已完成
3 期
Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mgProstatic NeoplasmsNCT02712320Foresee Pharmaceuticals Co., Ltd.30
进行中（未招募）
2 期
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing SyndromeCushing SyndromeNCT03604198Corcept Therapeutics125
已完成
2 期
A Study of Cariprazine in Patients With Chronic Stable SchizophreniaSchizophreniaNCT00839852Forest Laboratories97
已完成
3 期
Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic AsthmaAsthmaNCT00482248Novartis132