Alpha1-proteinase Inhibitor Deficiency

Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency

NCT00261833 | PHASE 4 | INTERVENTIONAL

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).

28 Sites

180 Participants

Recruiting

18 Years to 65 Years

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SUBMIT

Study Site

Denver,Colorado,United States,80206

Study Site

Miami,Florida,United States,33136

Study Site

Hershey,Pennsylvania,United States,17033

Study Site

Tyler,Texas,United States,75708

Study Site

Darlinghurst,New South Wales,Australia,2010

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New Lambton,New South Wales,Australia,2305

Study Site

Brisbane,Queensland,Australia,4066

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Adelaide,South Australia,Australia,5000

Study Site

Nedlands,Western Australia,Australia,6009

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Fitzroy,Australia,3065

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Vancouver,British Columbia,Canada,V5Z4E1

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Halifax,Nova Scotia,Canada,B3H3A7

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Toronto,Ontario,Canada,M5T2S8

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Praha,Czech Republic,14059

Study Site

Arhus,Denmark,8000

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Hellerup,Denmark,2900

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Tartu,Estonia,51014

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Oulu,Finland,90220

Study Site

Berlin,Germany,12200

Study Site

Essen,Germany,45239

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Heidelberg,Germany,69126

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Nürnberg,Germany,90419

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Dublin,Ireland,9

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Krakow,Poland,31-066

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Warsaw,Poland,01-138

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Bucuresti,Romania,011026

Study Site

Barnaul,Russian Federation

Study Site

Malmo,Sweden,20502

Study Eligibility Criteria

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov