NCT00242385已完成1 期
Single-Dose, Double-Blind, Crossover Study to Evaluate the Pharmacokinetic Comparability of ARALAST Fraction IV-1 Alpha1-Proteinase Inhibitor (ARALAST Fr. IV-1) and ARALAST
Baxalta now part of Shire7 个研究点 分布在 2 个国家目标入组 25 人开始时间: 2005年12月20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
- 25
- 试验地点
- 7
- 主要终点
- Area Under the Curve/Dose
研究概览
简要总结
The primary purpose of this study is to characterize the pharmacokinetic profile of intravenous Aralast Fraction (Fr.) IV-1, a sterile, stable, lyophilized preparation of functionally intact human Alpha1- Proteinase Inhibitor (α1-PI). This pharmacokinetic study will be a randomized controlled clinical trial with a cross-over design. Twenty-four subjects will be enrolled into the study. Overall study duration will be approximately 6-8 months.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（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
- •Subject is 18 years of age or older
- •Subject has a documented, endogenous plasma Alpha1-PI level < 8 Micromolar
- •Subject is of the genotype Pi*Z/Z, Pi*Z/Null, Pi*Null/Null, Pi*Malton/Z, or others, dependent on the approval by the Sponsor
- •If the subject is female or of childbearing potential, the subject has a negative urine test for pregnancy within 7 days prior to first study product administration and agrees to employ adequate birth control measures for the duration of the study
- •Laboratory results obtained at the screening visit, meeting the following criteria:
- •Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) <= 2 times the upper limit of normal (ULN)
- •Serum total bilirubin <= 2 times ULN
- •Proteinuria < +2 on dipstick analysis
- •Serum creatinine <= 1.5 times ULN
- •Absolute neutrophil count (ANC) >= 1500 cells/mm3
- •Hemoglobin >= 10.0 g/dL
- •Platelet count >= 10^5/mm3
- •If the subject is treated with any respiratory medications, including inhaled bronchodilators and inhaled or oral corticosteroids, the subjects´ medication doses were unchanged for at least 14 days prior to first study product administration
- •Nonsmoker for a minimum of 3 months prior to first study product administration
排除标准
- •The subject has received any Alpha1-PI augmentation therapy (including Aralast and investigational Alpha1-PIs, by any route including intravenous and inhaled) within 42 days prior to first study product administration
- •The subject has received an investigational drug or device within 1 month prior to first study product administration, or the subject is currently receiving an investigational drug
- •The subject has a known selective immunoglobulin A (IgA) deficiency (IgA level < 15 mg/dL) and/or antibody to IgA
- •The subject has a pulmonary exacerbation or had a pulmonary exacerbation in the past 14 days prior to first study product administration
- •The subject is pregnant or lactating, or intends to become pregnant during the course of the study
- •The subject has a 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
结局指标
主要结局
Area Under the Curve/Dose
时间窗: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion
Area under the plasma alpha1-proteinase inhibitor (α1-PI) concentration versus time curve (AUC) calculated by linear trapezoidal method per dose.
次要结局
- Mean Residence Time (MRT)(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
- Time to Maximum α1-PI Concentration Post-infusion (Tmax)(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
- Incremental Recovery(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
- Systemic Clearance (CL)(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
- Apparent Volume of Distribution at Steady State(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
- Adverse Events (AEs)(Throughout study period (7 months))
- Total Area Under the Curve Per Dose(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
- Terminal Half-life(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
- Maximum Plasma Concentration (Cmax)(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
研究者
研究点 (7)
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