A Randomized, Placebo-Controlled, Double-Blind, Multicenter Phase III/IV Study to compare the Efficacy and Safety of 60 mg/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 - N/A

CSL Behring GmbH0 个研究点目标入组 100 人开始时间: 2008年5月26日最近更新: 2012年10月2日

适应症

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•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 contraceptive methods deemed reliable by the investigator.
•Diagnosis of alpha1-proteinase inhibitor deficiency (serum A1-PI levels < 11 mM). 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 FEV1 >= 35 and <= 70% (predicted).
•No signs of chronic or acute Hepatitis B, Hepatitis C or HIV infection (negative serologies for HIV and viral hepatitis, IgM anti-HAV, HBsAg, IgM anti-HBc, and anti-HCV).
•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) no
•F.1.3.1 Number of subjects for this age range

•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).
•Conditions or behaviors that interfere with attending scheduled study visits in 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.

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