CTRI/2016/02/006686已完成未知
Pharmacokinetic study of Treosulfan in patients eligible for treosulfan based conditioning regimen prior to HSCT (Hematopoietic stem cell transplantation) - Treosulfan
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 15
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
入选标准
- •The subjects will be selected for study participation, if they meet the following criteria:
- •1. Class 3 patients with Thalassemia major and patients > 18 years of age with other haematological disorders requiring allogeneic HSCT.
- •2. Availability of appropriate HLA identical donor
- •3. Willful written informed consent as per regulatory requirements
- •4. Performance status 0 â?? 2 (karnofsky performance status >80%)
- •5. Agreed on adequate contraception in subjects of child bearing age
排除标准
- •Subjects will be excluded from the study, if they meet any of the following criteria:
- •1. Contraindications as per summary of product characteristics
- •2. H/o of psychiatric illness or malignant involvement of CNS
- •3. For Class 3 Thalassemia patients - Total Bilirubin 2 x ULN, SGOT & SGPT 5 x ULN is allowed, For other Haematological disorders - Total Bilirubin 2 x ULN, SGOT & SGPT 3 x ULN is allowed.
- •4. H/o of renal dysfunction (creatinine clearance less than 60ml/min
- •5. H/o of cardiac and other metabolic disorders
- •6. H/o respiratory dysfunction
- •7. HIV positive or active hepatitis or active infectious disease
- •8. Pregnancy and lactation
研究者
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