2022-501594-39-00招募中4 期
Pharmacokinetics of anti-lymphocyte serum in the prevention of GvHD in children and adults receiving allogeneic hematopoietic stem cell transplantation - PHASAL-GA Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Measurement of plasma SAL exposure (mean AUC and standard deviation in the study population), calculated using population PK methodology
研究概览
简要总结
characterize the pharmacokinetics (PK) of anti-lymphocyte serum (SAL), Thymoglobulin® in patients involved in a HSC transplantation procedure
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Thymoglobulin
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient receiving Thymoglobulin therapy as part of a first HSC allograft
- •Age ≥ 2 years
- •Lansky or Karnosky score ≥ 50%.
- •Enrolled in a social security plan
- •Patient 18 years of age or older informed and consenting to participate in the study or minor patient whose parents/guardians have been informed and have given consent for the minor patient's participation in the study
- •Patients of childbearing potential must have an effective method of contraception throughout the study (a pregnancy test will also be performed at inclusion). Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilisation, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices.
排除标准
- •Patient having received serotherapy (Thymoglobulin® or other) within 3 months before this HSC allograft
- •Patient receiving another serotherapy during conditioning (Campath®)
- •Patients with uncontrolled acute or chronic infections for which any form of immunosuppression would be contraindicated
- •Known hypersensitivity to Thymoglobulin®
- •Pregnant or lactating women
- •Patient participating simultaneously in another study of an investigational drug (no exclusion period)
- •Patient under legal protection or deprived of liberty
结局指标
主要结局
Measurement of plasma SAL exposure (mean AUC and standard deviation in the study population), calculated using population PK methodology
Measurement of plasma SAL exposure (mean AUC and standard deviation in the study population), calculated using population PK methodology
次要结局
- objective function value (OFV)
- Coefficient of variation of the AUC
研究者
Dr Michael PHILIPPE
Scientific
Hospices Civils De Lyon
研究点 (1)
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