Clinical research study to assess the safety and effectiveness of alpha1-proteinase inhibitor (A1-PI) administered by intravenous application to patients with alpha1-proteinase deficiency and emphysema who have completed the 2-year treatment and observation period in the Phase III/IV Zemaira® CE1226_4001.

• Conditions: Chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor (A1-PI) deficiency and clinical evidence of emphysema.; MedDRA version: 14.1Level: LLTClassification code 10001811Term: Alpha-1 proteinase inhibitor deficiencySystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2007-007129-38-FI
• Lead Sponsor: CSL Behring GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-31
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Subjects who have completed the 2-year treatment and observation period in the Phase 3/4 Zemaira® CE1226_4001 study and are willing to sign informed consent.

2. Males, and non-pregnant, non-lactating females, whose screening pregnancy test is negative and who are using contraceptive methods deemed reliable by the investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Individuals residing in the US.

2. Current evidence of alcohol abuse, or abuse of drugs, such as barbiturates, benzodiazepines, amphetamines, cocaine, opioids, and cannabinoids.

3. History of allergy, anaphylactic reaction, or severe systemic response to human plasma derived products, or known mannitol hypersensitivity, or history of prior adverse reaction (AR) to mannitol.

4. Current tobacco smoker (i.e. smoking must be discontinued for at least 6 months prior to study participation).

5. Conditions or behaviors that interfere with attending scheduled study visits, in the opinion of the investigator.

6. History of non-compliance.

7. Administration of any other experimental new drug or participation in an investigation of a marketed product.

8. Inability to perform necessary study procedures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified