NCT00289536已完成4 期
Advate Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (ADVATE rAHF-PFM): A Phase 4 Study to Determine the Pharmacokinetic Response of Patients Diagnosed With Severe Hemophilia A to Different Doses of ADVATE rAHF-PFM
Baxalta now part of Shire8 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2006年2月2日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 8
- 主要终点
- Initial Recovery
研究概览
简要总结
The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial recovery (% increase [IU/dL] per IU/kg infused) and major single-infusion pharmacokinetic parameters. The 3 doses are 15, 30, and 50 IU/kg. Prior to each infusion, subjects will not have received treatment with a factor VIII concentrate for at least 3 days. Blood samples will be drawn within 30 minutes pre-infusion and at 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32 and 48 hours post-infusion. A washout period of at least 3 days, but no more than 30 days between the last blood draw and the next infusion will be observed. During participation, subjects will maintain their preexisting treatment regimens with ADVATE rAHF-PFM or other factor VIII concentrate.
A secondary objective is to investigate the relationship between pharmacokinetic parameters at each dose level and the levels of von Willebrand factor ristocetin cofactor activity and von Willebrand factor antigen at baseline.
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
- 12 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 has severe hemophilia A as defined by a baseline factor VIII activity <1% of normal; tested at screening. (A minimum washout period of 3 days is required before the blood sample can be drawn to determine baseline factor VIII levels.)
- •The subject has a documented history of at least 150 exposure days to factor VIII concentrates (either plasma-derived or recombinant).
- •The subject is within 12 to 65 years of age.
- •The subject has a Karnofsky performance score >
- •The subject is human immunodeficiency virus negative (HIV-) or HIV+ with CD4 count >=400 cells/mm3 (CD4 count determined at screening, if necessary).
- •The subject or subject´s legally authorized representative has provided written informed consent.
排除标准
- •The subject has a known hypersensitivity to mouse or hamster proteins or to factor VIII concentrates.
- •The subject has a history of factor VIII inhibitors with titer >=0.8 BU (Bethesda Assay) or >=0.4 BU (Nijmegen modification of the Bethesda Assay) any time prior to screening.
- •The subject has a detectable factor VIII inhibitor at screening, >=0.4 BU (Nijmegen modification of the Bethesda Assay), in the Baxter 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´s Disease).
- •The subject has participated in another investigational study within 30 days of enrollment.
- •The subject´s clinical condition may require a major or moderate surgery (estimated blood loss >500 mL) during the period of participation in the study.
结局指标
主要结局
Initial Recovery
时间窗: Pharmacokinetic evaluations: 30 minutes pre-infusion to 30 minutes post-infusion
Percent increase in factor VIII concentration per dose from pre- to post-infusion
次要结局
- Maximum Plasma Concentration(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)
- Total Area Under the Curve(Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion)
- Pre-infusion Von Willebrand Factor Ristocetin Cofactor Activity (VWF:Rco)(At baseline and before each pharmacokinetic evaluation)
- Pre-infusion Von Willebrand Factor Antigen (VWF:Ag)(At baseline and before each pharmacokinetic evaluation)
- Area Under the Curve/Dose(Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion)
- Total Area Under the Moment Curve(Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion)
- Terminal Half-life(Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion)
- Area Under the Curve(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)
研究者
研究点 (8)
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