An Open-label, Pharmacokinetic, Pharmacodynamic, and Tolerability Study of AVE5026 Administered at Weight-adjusted Doses to Patients Less Than 18 Years of Age With a Central Venous Line (CVL)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Plasma concentrations of Semuloparin
研究概览
简要总结
Primary Objective:
- To assess the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of Semuloparin [AVE5026] (assessed from the anti-Xa activity of Semuloparin) in children in order to determine the dose to be assessed in a clinical efficacy/safety study in this population.
Secondary Objective:
- To assess the tolerability of Semuloparin when administered at a weight-adjusted, once daily dose for up to 30 days in patients less than 18 years of age with central venous line.
详细描述
The maximum study duration for a participant was 68 days broken down as follows:
- Screening period: up to 6 days,
- Treatment period: minimum 6 days and maximum 30 days,
- Follow-up period with an end of study visit performed 4 weeks (30 +/-2 days) post treatment.
Enrollment staggered by age group starting with the older children (≥12 years). In each younger age group, enrolment was planned to initiate only following a review by the Data Monitoring Committee (DMC) of the clinical safety data and available PK and PD data from the first 3 out of 7 children from the previous older age group. Enrollment of infants <3 months was planned to initiate after recruitment of all patients ≥3 months had been completed and all data analyzed by the DMC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Age group from 12 to 18 (<) years
Semuloparin sodium, weight-adjusted dose once daily for 6-30 days
干预措施: Semuloparin sodium (Drug)
Age group from 6 to 12 (<) years
Semuloparin sodium, weight-adjusted dose once daily for 6-30 days
干预措施: Semuloparin sodium (Drug)
Age group from 2 to 6 (<) years
Semuloparin sodium, weight-adjusted dose once daily for 6-30 days
干预措施: Semuloparin sodium (Drug)
Age group from 3 months to 2 (<) years
Semuloparin sodium, weight-adjusted dose once daily for 6-30 days
干预措施: Semuloparin sodium (Drug)
Age group from birth to 3 (<) months
Semuloparin sodium, weight-adjusted dose once daily for 6-30 days
干预措施: Semuloparin sodium (Drug)
结局指标
主要结局
Pharmacokinetics: Plasma concentrations of Semuloparin
时间窗: 6 samples; 0.5-1h and 6h after D4 injection, 1.5-4h and 12h after D5 injection, just before and 8h after D6 injection
A validated anti-Xa chromogenic enzyme assay, with addition of AT-III in excess was to be used to assess plasma concentrations of semuloparin. A full population PK model of semuloparin in children (including covariates assessment) was to be established and individual pharmacokinetic parameters were be estimated.
Pharmacodynamic activity (anti-Xa activity) of Semuloparin
时间窗: 6 samples; 0.5-1h and 6h after D4 injection, 1.5-4h and 12h after D5 injection, just before and 8h after D6 injection
A validated anti-Xa chromogenic enzyme assay, without addition of AT-III in excess, was to be used to assess pharmacodynamic activity (factor Xa inhibition) of semuloparin. A full population PK/PD model of semuloparin in children (including covariates assessment) was to be established and individual pharmacodynamic parameters were to be estimated.
次要结局
- Safety parameters including liver and renal laboratory data(up to 30+/- 2 days post treatment)
- Safety parameters including serious adverse events(up to 30+/- 2 days post treatment)
- Safety parameters including bleeding(up to 30+/- 2 days post treatment)
- Safety parameters including non-serious adverse events(up to 30+/- 2 days post treatment)
- Safety parameters including transfusions requirement(up to 30+/- 2 days post treatment)
- Safety parameters including hemoglobin, platelet count(up to 30+/- 2 days post treatment)