JPRN-UMIN000038973已完成3 期
A multicenter, phase 3 study assessing efficacy and safety of the Sirolimus (Granules and Tablets) in the Treatment of intractable vascular anomalies - Sirolimus for Intractable Vascular Anomalies(SIVA)
Gifu University Hospital0 个研究点目标入组 10 人开始时间: 2019年12月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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
- 1months-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Past usage of mTOR inhibitors excluding sirolimus or other molecular target drugs relating mTOR pathway within 8 weeks 2) Patients who currently have an uncontrolled infection 3) Karnofsky Performance Status (PS) <= 30 (10 years of age) or Lansky play PS <= 30 (< 10 years of age) 4) Interstitial lung disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, chronic liver disease, or chronic renal disease 5) Chronic treatment (>= 4 weeks) with systemic steroids or another immunosuppressive agent at entry. Patients with endocrine deficiencies are allowed to receive physiologic or stress doses of steroids if necessary. 6) History of allergy to sirolimus, or additive substance 7) Patients must also avoid strong inducers of CYP3A4, and may not have received these medications within 1 week of entry. 8) Known history of HIV seropositivity or known immunodeficiency 9) Hepatitis B virus carrier and/or Hepatitis C virus carrier 10) Malabsorption of sirolimus 11) Patients who have undergone surgical resection or interventional radiology procedures for target lesions within 2 weeks 12) Patients who have received therapeutic medication for a target disease within 2 weeks 13) Patients who have received chemotherapy drugs that cause bone marrow suppression, biological drug, or off-label products within 4 weeks 14) Patients who have received radiation therapy for target lesions within 24 weeks 15) Patients who have participated another clinical trial within 4 weeks 16) Patients who have dental braces or prosthesis only if it interferes with radiologic analysis of lymphatic anomaly 17) Pregnant, probably pregnant, or breast-feeding woman. Patients or their partners who do not agree birth control during clinical trial. 18) Patients who have participated in clinical trial of sirolimus in the past. 19) Patient who is judged inappropriate to participate in this study by the investigators
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