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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00670007
Registration number
NCT00670007
Ethics application status
Date submitted
29/04/2008
Date registered
1/05/2008
Date last updated
15/08/2016
Titles & IDs
Public title
Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.
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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
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Secondary ID [1]
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1466
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Secondary ID [2]
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CE1226_3001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Emphysema
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Alpha 1-proteinase Inhibitor Deficiency
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Alpha1- proteinase inhibitor [human]
Experimental: Zemaira® -
Other interventions: Alpha1- proteinase inhibitor [human]
Lyophilized preparation of 60 mg/kg body weight intravenously once per week
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of Change of Adjusted Lung Density
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Assessment method [1]
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As measured by centralized, standardized computer tomographic (CT) lung densitometry. CT scans were acquired at 2 inspiration states: TLC (Total Lung Capacity; ie, full inspiration) and FRC (Functional Residual Capacity; ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average rate of decline in the early start and delayed start subgroups from a linear random regression model with country, inspiration state (only for 'TLC and FRC state'), time (time elapsed since Day 1 [CE1226_4001]), treatment and treatment by time interaction as fixed effects and subject and subject by time interaction as random coefficients.
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Timepoint [1]
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Up to 2 years
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Secondary outcome [1]
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Absolute Change in Adjusted Lung Density
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Assessment method [1]
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Absolute change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average absolute change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226_4001.
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Timepoint [1]
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From baseline to 2 years
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Secondary outcome [2]
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Percent Change in Adjusted Lung Density
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Assessment method [2]
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Percent change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average percent change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226_4001.
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Timepoint [2]
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From baseline to 2 years
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Secondary outcome [3]
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Change in Subject-reported Symptoms
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Assessment method [3]
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Patient-reported symptoms were measured using the St George's Respiratory Questionnaire (SGRQ). SGRQ total, symptoms, activity and impact scores range from 0 to 100, with higher scores indicating more limitations, and change from baseline below zero (0) is favorable, indicating improvement.
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Timepoint [3]
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From baseline to 2 years
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Secondary outcome [4]
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Percent Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1)
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Assessment method [4]
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Timepoint [4]
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From baseline up to 2 years
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Secondary outcome [5]
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Percent Change in Lung Function as Measured by Ratio of FEV1/FVC (Forced Vital Capacity)
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Assessment method [5]
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Timepoint [5]
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From baseline up to 2 years
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Secondary outcome [6]
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Percent Change in Lung Function as Measured by Percent Predicted FEV1
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Assessment method [6]
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Timepoint [6]
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From baseline up to 2 years
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Secondary outcome [7]
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Number of Subjects With Pulmonary Exacerbations
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Assessment method [7]
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Timepoint [7]
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Up to 2 years
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Secondary outcome [8]
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Annual Rate in Subject Years of Pulmonary Exacerbations
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Assessment method [8]
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Annual exposure-adjusted incidence rate of pulmonary exacerbations.
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Timepoint [8]
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Up to 2 years
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Secondary outcome [9]
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Time to First Pulmonary Exacerbation
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Assessment method [9]
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Timepoint [9]
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Up to 2 years
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Secondary outcome [10]
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Percentage of Subjects With Treatment Emergent Adverse Events
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Assessment method [10]
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Percentage of subjects with treatment-emergent adverse events (TEAEs): overall, by severity, by relatedness, by seriousness, and which occurred within 24 hours of Zemaira administration.
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Timepoint [10]
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From baseline up to 2.5 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2014
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Sample size
Target
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Accrual to date
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Final
140
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Study Site - Adelaide
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Recruitment hospital [2]
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Study Site - Fitzroy
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Recruitment hospital [3]
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Study Site - Darlinghurst
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Recruitment hospital [4]
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Study Site - Nedlands
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Recruitment hospital [5]
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Study Site - New Lambton
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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2010 - Darlinghurst
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment postcode(s) [5]
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2305 - New Lambton
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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British Columbia
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Country [2]
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Canada
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State/province [2]
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Nova Scotia
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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Czech Republic
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State/province [4]
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Praha 4 - Krc
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Country [5]
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Denmark
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State/province [5]
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Arhus C
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Country [6]
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Denmark
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State/province [6]
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Hellerup
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Country [7]
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Estonia
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State/province [7]
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Tartu
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Country [8]
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Finland
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State/province [8]
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Oulu
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Country [9]
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Germany
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State/province [9]
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Essen
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Country [10]
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Germany
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State/province [10]
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Heidelberg
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Country [11]
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Germany
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State/province [11]
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Nürnberg
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Country [12]
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Ireland
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State/province [12]
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Dublin
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Country [13]
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Poland
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State/province [13]
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Krakow
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Country [14]
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Poland
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State/province [14]
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Warsaw
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Country [15]
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Romania
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State/province [15]
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Bucuresti
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Country [16]
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Sweden
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State/province [16]
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Malmo
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
CSL Behring
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00670007
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Program Director, Clinical R&D
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Address
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CSL Behring
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00670007
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