NCT00261833已完成4 期
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Phase III/IV Study to Compare the Efficacy and Safety of 60mg/kg Body Weight of Zemaira® Weekly I.V. Administration With Placebo Weekly I.V. Administration in Chronic Augmentation and Maintenance Therapy in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 180
- 试验地点
- 29
- 主要终点
- Annual Rate of Change in Lung Density
研究概览
简要总结
This is a randomized, placebo-controlled, double-blind, multicenter phase III/IV study to compare the efficacy and safety of Zemaira® with placebo in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The effect of Zemaira® on the progression of emphysema will be assessed by the decline of lung density, measured by computed tomography (CT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years of age and willing to sign informed consent.
- •Males and non-pregnant, non-lactating females whose screening pregnancy test is negative and who are using contraceptives methods deemed reliable by the investigator.
- •Diagnosis of alpha1-proteinase inhibitor (A1-PI) deficiency (serum A1-PI levels < 11 μM or < 80 mg/dL). This includes newly diagnosed subjects, previously untreated subjects, currently treated subjects, and subjects currently not on treatment therapy but on treatment in the past.
- •Subjects with emphysema and forced expiratory volume in 1 second (FEV1) ≥ 35% and ≤ 70% (predicted).
- •No signs of chronic or acute Hepatitis A, Hepatitis B, Hepatitis C or HIV infection (negative serologies for HIV and viral hepatitis). In case of positive serologies for viral hepatitis, vaccination status or negative IgM should be available.
排除标准
- •Any relevant chronic diseases or history of relevant diseases (e.g., severe renal insufficiency) except respiratory or liver disease secondary to alpha1-proteinase inhibitor deficiency. Subjects with well-controlled, chronic diseases may be included after consultation with the treating physician and the sponsor.
- •Current evidence of alcohol abuse or history of abuse of illegal and/or legally prescribed drugs such as barbiturates, benzodiazepines, amphetamines, cocaine, opioids, and cannabinoids.
- •History of allergy, anaphylactic reaction, or severe systemic response to human plasma derived products, or known mannitol hypersensitivity, or history of prior adverse reaction to mannitol.
- •History of transfusion reactions.
- •Selective IgA deficiency.
- •Acute illness within one week prior to the first administration of the investigational medicinal product (IMP). Start of treatment after recovery is possible.
- •Current tobacco smoker (smoking has to be ceased at least 6 months prior study inclusion). Subjects with a positive cotinine test due to nicotine replacement therapy (e.g. patches, chewing gum) or snuff are eligible.
- •Conditions or behaviors that interfere with attending scheduled study visits in the opinion of the investigator.
- •History of non-compliance.
- •Administration of any other experimental new drug or participation in an investigation of a marketed product within one month prior to the screening visit date.
- •Inability to perform necessary study procedures.
- •Lung transplantation, lung volume reduction surgery or lobectomy or being on a waiting list for any such surgeries.
结局指标
主要结局
Annual Rate of Change in Lung Density
时间窗: Over a 2-year period
As measured by centralized, standardized computer tomographic (CT) lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average rate of decline in each treatment group.
次要结局
- Change in Lung Density(From baseline to 2 years)
- Annual Rate of Pulmonary Exacerbations(Over a 2-year period)
- Percent Change in FEV1(From baseline to 2 years)
- Time to First Pulmonary Exacerbation(Over a 2-year period)
- Change in Exercise Capacity(From baseline to 2 years)
- Change in Patient-reported Symptoms(From baseline to 2 years)
- Frequency and Intensity of Adverse Events (AEs)(Over a 2-year period)
- Percent Change in FEV1 Divided by Forced Vital Capacity(From baseline to 2 years)
- Percent Change in DLCO(From baseline to 2 years)
- Percent Change in Percent Predicted FEV1(From baseline to 2 years)
- Duration of Pulmonary Exacerbations Relative to Treatment Duration(Over a 2-year period)
- Severity of Pulmonary Exacerbations(Over a 2-year period)
研究者
研究点 (29)
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