NCT00666406已完成4 期
Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A: a Phase IV, Prospective, Randomized, Controlled, Cross-over, Single Center Study
Baxalta now part of Shire0 个研究点目标入组 9 人开始时间: 2008年3月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 主要终点
- Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe hemophilia A (factor VIII level < 1%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent obtained from participant or legally authorized representative
- •15-60 years old
- •Factor VIII level < 1% as documented by previously measured factor VIII and genotyping
- •Previously treated with factor VIII concentrate(s) for a minimum of at least 150 exposure days (as documented by the study site investigator) prior to study entry
- •Observed decrease of efficacy by subject and/or treating physician after being switched from Recombinate rAHF to Advate rAHF-PFM
排除标准
- •The participant has a detectable factor VIII inhibitor at screening, with a titer >= 0.4 Bethesda Unit (BU) (Nijmegen modification of the Bethesda Assay) measured at the local and the central laboratory
- •The participant has a known hypersensitivity to mouse or hamster proteins
- •The participant is participating in another investigational drug study within 30 days prior to screening
- •The participant is identified by the investigator as being unable or unwilling to cooperate with study procedures
研究组 & 干预措施
1
Experimental
Advate rAHF-PFM
干预措施: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) (Drug)
2
Active Comparator
Recombinate rAHF
干预措施: Recombinant Factor VIII (rAHF) (Drug)
结局指标
主要结局
Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
时间窗: 0-30 minutes before infusion up to 48 hours post-infusion
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
时间窗: 0-30 minutes before infusion up to 48 hours post-infusion
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. One-Stage Activated Partial Thromboplastin Time (aPTT) -Based Assay Performed at Central Laboratory (Medical University Vienna)
时间窗: 0-30 minutes before infusion up to 48 hours post-infusion
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
时间窗: 0-30 minutes before infusion up to 48 hours post-infusion
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
次要结局
- Maximum Plasma Concentration (C-max). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Systemic Clearance (Cl). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Maximum Plasma Concentration (C-max). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Terminal Half-life. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Incremental Recovery. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)(0-30 minutes before infusion up to 48 hours post-infusion)
- Mean Residence Time (MRT). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Time to Reach the Maximum Plasma Concentration (Tmax). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)(0-30 minutes before infusion up to 48 hours post-infusion)
- Volume of Distribution at Steady State (Vss). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)(0-30 minutes before infusion up to 48 hours post-infusion)
- Systemic Clearance (Cl). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)(0-30 minutes before infusion up to 48 hours post-infusion)
- Systemic Clearance (Cl). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Maximum Plasma Concentration (C-max). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)(0-30 minutes before infusion up to 48 hours post-infusion)
- Systemic Clearance (Cl). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Terminal Half-life. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Mean Residence Time (MRT). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Mean Residence Time (MRT). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Time to Reach the Maximum Plasma Concentration (Tmax). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Volume of Distribution at Steady State (Vss). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Terminal Half-life. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)(0-30 minutes before infusion up to 48 hours post-infusion)
- Incremental Recovery. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Volume of Distribution at Steady State (Vss). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)(0-30 minutes before infusion up to 48 hours post-infusion)
- Maximum Plasma Concentration (C-max). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Terminal Half-life. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Time to Reach the Maximum Plasma Concentration (Tmax). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Volume of Distribution at Steady State (Vss). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Incremental Recovery. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Incremental Recovery. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
- Mean Residence Time (MRT). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)(0-30 minutes before infusion up to 48 hours post-infusion)
- Time to Reach the Maximum Plasma Concentration (Tmax). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)(0-30 minutes before infusion up to 48 hours post-infusion)
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