An open-label, 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

CSL Behring GmbH0 个研究点目标入组 140 人开始时间: 2009年1月20日最近更新: 2014年4月14日

适应症

试验速览

暂无简介。

•1. Subjects who have completed the 2-year treatment and observation period in the Phase 3/4 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 125
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•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 (AR) to mannitol.
•4. Current tobacco smoker (i.e. smoking must be discontinued for at least 6 months prior to study participation).
•5. Conditions or behaviors that interfere with attending scheduled study visits, in the 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.

发起方