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

CSL Behring

Status and phase: Completed; Phase 4

Conditions: Alpha 1-proteinase Inhibitor Deficiency; Emphysema

Treatments: Biological: Alpha1- proteinase inhibitor [human]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00670007

2007-007129-38 (EudraCT Number)

1466 (Other Identifier)

CE1226_3001

Details and patient eligibility

About

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).

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

Zemaira®

Experimental group

Treatment:

Biological: Alpha1- proteinase inhibitor [human]