NCT00496262已完成2 期
Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 15
- 试验地点
- 16
- 主要终点
- Maximum Clot Firmness (MCF)
研究概览
简要总结
This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and clot strength (maximum clot firmness [MCF]) in subjects with congenital fibrinogen deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen when a fixed dose of human fibrinogen concentrate was administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 6 years
- •Documented congenital fibrinogen deficiency: fibrinogen deficiency manifested as afibrinogenemia with plasma fibrinogen activity and antigen at screening undetectable (i.e. < 20 mg/dL)
- •Informed consent signed by subject or legal guardian
排除标准
- •Presence or history of hypersensitivity to Human Fibrinogen Concentrate or human plasma proteins,
- •Presence or history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis
- •Acute bleeding
- •History of esophageal varicose bleeding
- •End stage liver disease (i.e. Child-Pugh score B or C)
- •Planned major surgery with a need for blood transfusion during the PK blood sampling period
- •Polytrauma within 1 year prior to enrollment
结局指标
主要结局
Maximum Clot Firmness (MCF)
时间窗: Pre-infusion and 1 hour post-infusion
MCF is a functional parameter that depends on the activation of coagulation, the fibrinogen content of the sample (in plasma), and the polymerization and crosslinking of the fibrin network. MCF was determined by rotational thromboelastometry (ROTEM) testing.
次要结局
- Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose(Pre-infusion to 13 days post-infusion)
- Classical In Vivo Recovery (IVR)(Pre-infusion to 4 hours post-infusion)
- Maximum Concentration (Cmax)(Pre-infusion to 13 days post-infusion)
- Clearance (Cl)(Pre-infusion to 13 days post-infusion)
- Volume of Distribution at Steady State (Vss)(Pre-infusion to 13 days post-infusion)
- Incremental In Vivo Recovery (IVR)(Pre-infusion to 4 hours post-infusion)
- Terminal Elimination Half-life (t1/2)(0.5 hours to 13 days post-infusion)
- Mean Residence Time (MRT)(Pre-infusion to 13 days post-infusion)
研究者
研究点 (16)
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