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

Completed · Phase 4 · Has a placebo group

Conditions studied: Alpha1-proteinase Inhibitor Deficiency, Emphysema

In brief

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).

Key facts

Study ID

NCT00261833

Run by

CSL Behring

People needed

180

Starts

2006-03-01

Expected to finish

2012-09-01

Last updated by the study team

2015-01-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study Site — Denver, Colorado, United States
• Study Site — Miami, Florida, United States
• Study Site — Hershey, Pennsylvania, United States
• Study Site — Tyler, Texas, United States
• Study Site — Darlinghurst, New South Wales, Australia
• Study Site — New Lambton, New South Wales, Australia
• Study Site — Brisbane, Queensland, Australia
• Study Site — Adelaide, South Australia, Australia
• Study Site — Nedlands, Western Australia, Australia
• Study Site — Fitzroy, Australia
• Study Site — Vancouver, British Columbia, Canada
• Study Site — Halifax, Nova Scotia, Canada
• Study Site — Toronto, Ontario, Canada
• Study Site — Prague, Czechia
• Study Site — Aarhus, Denmark
• Study Site — Hellerup, Denmark
• Study Site — Tartu, Estonia
• Study Site — Oulu, Finland
• Study Site — Berlin, Germany
• Study Site — Essen, Germany
• Study Site — Heidelberg, Germany
• Study Site — Nuremberg, Germany
• Study Site — Dublin, Ireland
• Study Site — Krakow, Poland
• Study Site — Warsaw, Poland

Full record on ClinicalTrials.gov

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