NCT00952822已完成1 期
A Phase 1, Prospective, Randomized, Crossover Study to Compare the Pharmacokinetics and Safety of rAHF-PFM Reconstituted in 2 mL Versus 5 mL SWFI in Previously Treated Severe Hemophilia A Patients
Baxalta now part of Shire11 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2008年8月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 11
- 主要终点
- Area Under the Curve
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics and safety of Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) reconstituted in 2 mL sterile water for injection (SWFI) and compare with those of rAHF-PFM reconstituted in 5 mL of SWFI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject or subject's legally authorized representative has provided written informed consent
- •The subject has severe hemophilia A as defined by a baseline FVIII activity <= 1% of normal; tested at screening
- •The adolescent/adult subject has a documented history of at least 150 exposure days to FVIII concentrates (either plasma-derived or recombinant), and the pediatric subject has at least 50 exposure days
- •The subject is >= 12 to <= 65 years of age for the complete pharmacokinetic assessment and >= 2 to < 12 years for the incremental recovery assessment The subject has a Karnofsky performance score > 60
- •The subject is human immunodeficiency virus negative (HIV-) or HIV+ with stable CD4 count >= 200 cells/mm³ (CD4 count determined at screening, if necessary)
排除标准
- •The subject has a known hypersensitivity to mouse or hamster proteins or to FVIII concentrates
- •The subject has a history of FVIII inhibitors with titer >=
- •5 BU (Bethesda Assay) or >= 0.4 BU (Nijmegen modification of the Bethesda Assay) any time prior to screening
- •The subject has a detectable FVIII inhibitor at screening, >= 0.4 BU (Nijmegen modification of the Bethesda Assay), in the central laboratory
- •The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) > 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices
- •The subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (e.g. qualitative platelet defect or Von Willebrand Disease)
- •The subject has received another investigational product within 30 days of enrollment
- •The subject's clinical condition may require major or moderate surgery (estimated blood loss > 500 mL) during the period of participation in the study
- •Subjects with clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance
- •The subject is a female of childbearing potential with a positive pregnancy test at screening
结局指标
主要结局
Area Under the Curve
时间窗: Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion
Area under the factor VIII (FVIII) plasma concentration versus time curve (AUC) from 0 to 48 hours estimated using the linear trapezoidal method
次要结局
- Total Area Under the Curve(Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion)
- Adjusted in Vivo Incremental Recovery(Pharmacokinetic evaluations: 30 minutes pre-infusion to 30 minutes post-infusion)
- Terminal Half-life(Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion)
- Weight-Adjusted Clearance(Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion)
- Mean Residence Time(Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion)
- Volume of Distribution at Steady State(Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion)
- Maximum Plasma Concentration(Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion)
- Number and Severity of Infusion Site Reactions(Within 5 minutes pre-infusion up to 24 hours post-infusion)
- Infusion Site Pain(Within 5 minutes post-infusion up to 24 hours post-infusion)
研究者
研究点 (11)
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