NCT00161707已完成1 期
Phase I Safety Investigation of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency
Baxalta now part of Shire8 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2003年1月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Number of participants who develop antibodies to Recombinant Alpha 1-Antitrypsin (rAAT)
研究概览
简要总结
The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the short-term safety of inhaled recombinant alpha 1-antitrypsin (rAAT) in subjects with alpha 1-antitrypsin deficiency. The subjects are randomized to receive placebo or one of 4 doses of rAAT. The 4 doses are tested in a consecutive manner from lowest to highest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
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
- •Male or female 18 years of age or older
- •Endogenous plasma AAT levels < 11 µM (< 80 mg/dL)
- •Baseline forced expiratory volume at one second (FEV1) that is >= 50% of predicted, measured 30 minutes after a short-acting inhaled bronchodilator
- •Baseline arterial oxygen percent saturation (SaO2) within the normal limits for the individual study site
- •For subjects receiving an inhaled corticosteroid, β-2 agonist (eg, albuterol via metered dose inhaler [MDI]) or anticholinergic bronchodilator (eg, ipratropium bromide), treatment on a stable dose for at least 14 days prior to randomization
- •If female of childbearing potential, negative urine pregnancy test within 3 days prior to randomization and agreement to employ adequate birth control measures
- •No clinically significant abnormalities detected on a 12-lead electrocardiogram (ECG) performed no more than 7 days prior to randomization
- •Baseline laboratory results, obtained no more than 7 days prior to randomization, meeting the following criteria:
- •Serum aspartate transaminase (AST) and alanine transaminase (ALT) <= 2 times upper limit of normal range (ULN)
- •Serum total bilirubin <= 2 times ULN
- •< 2+ proteinuria on urine dipstick
- •Serum creatinine <= 1.5 times ULN
- •Absolute neutrophil count >= 1500 cells/mm3
- •Hemoglobin >= 10.0 g/dL
- •Platelet count >= 100,000/mm3
- •Signed informed consent
排除标准
- •Clinically significant pulmonary impairment, other than emphysema and/or chronic bronchitis
- •Clinically significant cardiac, hemostatic, or neurologic impairment, or other significant medical condition that, in the opinion of the investigator, would affect subject safety or compliance
- •Psychiatric or cognitive disturbance or illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance
- •Acute exacerbation of emphysema (as defined in Section 8.5.10) within 28 days prior to randomization
- •Pregnancy or lactation
- •Known history of allergy to yeast products
- •Medical history precluding the use of epinephrine or other rescue medication for treatment of anaphylaxis
- •Use of antihistamines within 7 days prior to randomization
- •Use of oral steroids, beta-blockers, or tricyclic antidepressants within 28 days prior to randomization
- •Use of another investigational drug or investigational device within 28 days prior to randomization
- •Any upper or lower respiratory infection within 28 days prior to randomization
结局指标
主要结局
Number of participants who develop antibodies to Recombinant Alpha 1-Antitrypsin (rAAT)
时间窗: 6 weeks after the first inhalation of study drug
次要结局
未报告次要终点
研究者
研究点 (8)
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