Extension Study of Zemaira� i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.
Information source: CSL Behring
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Emphysema; Alpha 1-proteinase Inhibitor Deficiency
Intervention: Alpha1- proteinase inhibitor [human] (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: CSL Behring Official(s) and/or principal investigator(s): Program Director, Clinical R&D, Study Director, Affiliation: CSL Behring
Summary
This study is a continuation of the placebo-controlled study CE1226_4001 (NCT00261833) to
evaluate the efficacy and safety of Zemaira® 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).
Clinical Details
Official title: 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
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Rate of change of lung density
Secondary outcome: Number of pulmonary exacerbationsLung function as measured by forced expiratory volume in 1 second (FEV1) Change in adjusted lung density Percent change in adjusted lung density Quality of Life (QoL) Lung function as measured by ratio of FEV1/FVC (forced vital capacity) Annual rate of pulmonary exacerbations Time to first onset of pulmonary exacerbation
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Study Site, Darlinghurst 2010, Australia
Study Site, Nedlands 6009, Australia
Study Site, New Lambton 2305, Australia
Study Site, Praha 4 - Krc 14059, Czech Republic
Study Site, Arhus C 8000, Denmark
Study Site, Hellerup 2900, Denmark
Study Site, Tartu 51014, Estonia
Study Site, Oulu 90220, Finland
Study Site, Essen 45209, Germany
Study Site, Heidelberg 69126, Germany
Study Site, Nürnberg 90419, Germany
Study Site, Dublin 9, Ireland
Study Site, Krakow 31-066, Poland
Study Site, Warsaw 01-138, Poland
Study Site, Bucuresti 011026, Romania
Study Site, Malmo 20502, Sweden
Study Site, Vancouver, British Columbia V5Z4E1, Canada
Study Site, Halifax, Nova Scotia B3H 3A7, Canada
Study Site, Toronto, Ontario M5T 2S8, Canada
Study Site, Adelaide, South Australia 5000, Australia
Study Site, Fitzroy, Victoria 3065, Australia
Additional Information
Click here to request more information about this study
Starting date: April 2008
Last updated: September 30, 2014
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