Emphysema

Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.

NCT00670007 | PHASE 4 | INTERVENTIONAL

This study is a continuation of the placebo-controlled study CE1226_4001 (NCT00261833) to evaluate the efficacy and safety of Zemaira® intravenous (i.v). administration in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The long-term verification of a disease-modifying benefit of Zemaira® on the progression of emphysema will be assessed by volume-adjusted lung density, measured yearly by computed tomography (CT).

21 Sites

140 Participants

Recruiting

18 Years to 12 Years

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Find closest sites:

SUBMIT

Study Site

Adelaide,South Australia,Australia,5000

Study Site

Fitzroy,Victoria,Australia,3065

Study Site

Darlinghurst,Australia,2010

Study Site

Nedlands,Australia,6009

Study Site

New Lambton,Australia,2305

Study Site

Vancouver,British Columbia,Canada,V6J1S3

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Halifax,Nova Scotia,Canada,B3H3A7

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Toronto,Ontario,Canada,M5T2S8

Study Site

Praha 4 - Krc,Czech Republic,14059

Study Site

Arhus C,Denmark,8000

Study Site

Hellerup,Denmark,2900

Study Site

Tartu,Estonia,51014

Study Site

Oulu,Finland,90220

Study Site

Essen,Germany,45239

Study Site

Heidelberg,Germany,69126

Study Site

Nürnberg,Germany,90419

Study Site

Dublin,Ireland,9

Study Site

Krakow,Poland,31-066

Study Site

Warsaw,Poland,01-138

Study Site

Bucuresti,Romania,011026

Study Site

Malmo,Sweden,20502

Study Eligibility Criteria

Inclusion Criteria

* Subjects who have completed the 2-year treatment and observation period in the Phase 3/4 Zemaira® CE1226_4001 study (NCT00261833) and are 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

Exclusion Criteria

* Individuals residing in the US
* Current evidence of alcohol abuse or abuse of 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
* Current tobacco smoker (smoking must be discontinued for at least 6 months prior to study participation)
* 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
* Inability to perform necessary study procedures

Additional Studies

Additional studies can be found at ClinicalTrials.gov