JPRN-UMIN000028429已完成2 期
Multicenter randomized double-blind comparison test followed by open-label continuous administration test of NPC-12T for Fibrodysplasia Ossificans Progressiva - Investigator-initiated clinical trial of NPC-12T for Fibrodysplasia Ossificans Progressiva
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
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
- 6years-old 至 59years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Patients with acute or chronic infection 2. Patients with skin sore reaching dermis 3. Patients experiencing flare-up during last 90 days 4. Past usage of mTOR inhibitors or other molecular target drugs relating mTOR pathway 5. Usage of medicine or foods which are prohibited for concurrent use of Sirolimus 6. History of allergy to Sirolimus, Sirolimus derivatives or additive substance 7. Patients with HBV, with the history of HBV or with active type-C hepatitis. 8. Severe abnormality in blood or liver function 9. Uncontrollable abnormal lipid metabolism 10. Renal failure 11. Immunodeficiency including HIV or primary immunodeficiency 12. Patients who are not able to take tablet, or who have gastrointestinal disorders possibly leading to insufficient absorption of Sirolimus 13. Patients who had surgery during 8 weeks before the registry 14. Pregnant, probably pregnant, or breast-feeding women. Patients who do not agree birth control during clinical trial.
研究者
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