EUCTR2007-007129-38-DE进行中（未招募）不适用
An open, non-controlled, multicenter, multinational Study to evaluate the Efficacy and Safety of Zemaira® administration in Chronic Augmentation and Maintenance Therapy in Subjects with Emphysema due to Alpha1-Proteinase Inhibitor Deficiency who completed Clinical Study CE1226_4001
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects who have completed the 2-year treatment and observation period in the Phase III/IV Zemaira® CE1226_4001 study and are willing to sign informed consent.
- •2. Males, and non-pregnant, non-lactating females, whose screening pregnancy test is
- •negative and who are using contraceptive methods deemed reliable by the investigator.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Individuals residing in the US.
- •2. Current evidence of alcohol abuse or abuse of drugs such as barbiturates, benzodiazepines, amphetamines, cocaine, opioids, and cannabinoids.
- •3. 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.
- •4. Current tobacco smoker (smoking has to be ceased at least 6 months prior study inclusion).
- •5. Conditions or behaviors that interfere with attending scheduled study visits in opinion of the investigator.
- •6. History of non-compliance.
- •7. Administration of any other experimental new drug or participation in an investigation of a marketed product.
- •8. Inability to perform necessary study procedures.
研究者
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