Status:
COMPLETED
Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.
Lead Sponsor:
CSL Behring
Conditions:
Emphysema
Alpha 1-proteinase Inhibitor Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00670007
Start Date
April 1 2008
End Date
September 1 2014
Last Update
August 15 2016
Active Locations (21)
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1
Study Site
Adelaide, South Australia, Australia, 5000
2
Study Site
Fitzroy, Victoria, Australia, 3065
3
Study Site
Darlinghurst, Australia, 2010
4
Study Site
Nedlands, Australia, 6009