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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00670007
• Date of registration: 29/04/2008
• Prospective Registration: No
• Primary sponsor: CSL Behring
• Public title: Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.
• Scientific 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
• Date of first enrolment: April 2008
• Target sample size: 140
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00670007
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Australia, Canada, Czech Republic, Denmark, Estonia, Finland, Germany, Ireland, Poland, Romania, Sweden

Contacts

• Name: Program Director, Clinical R&D
• Affiliation: CSL Behring

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Emphysema

Alpha 1-proteinase Inhibitor Deficiency

Intervention(s)

Biological: Alpha1- proteinase inhibitor [human]

Primary Outcome(s)

Rate of Change of Adjusted Lung Density [Time Frame: Up to 2 years]

Secondary Outcome(s)

Percent Change in Lung Function as Measured by Percent Predicted FEV1 [Time Frame: From baseline up to 2 years]

Percent Change in Lung Function as Measured by Ratio of FEV1/FVC (Forced Vital Capacity) [Time Frame: From baseline up to 2 years]

Percent Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) [Time Frame: From baseline up to 2 years]

Absolute Change in Adjusted Lung Density [Time Frame: From baseline to 2 years]

Percentage of Subjects With Treatment Emergent Adverse Events [Time Frame: From baseline up to 2.5 years]

Time to First Pulmonary Exacerbation [Time Frame: Up to 2 years]

Annual Rate in Subject Years of Pulmonary Exacerbations [Time Frame: Up to 2 years]

Number of Subjects With Pulmonary Exacerbations [Time Frame: Up to 2 years]

Change in Subject-reported Symptoms [Time Frame: From baseline to 2 years]

Percent Change in Adjusted Lung Density [Time Frame: From baseline to 2 years]

Secondary ID(s)

1466

2007-007129-38

CE1226_3001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/07/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00670007