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

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ClinicalTrials.gov Identifier: NCT00670007
Recruitment Status : Completed
First Posted : May 1, 2008
Results First Posted : July 12, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Emphysema
Alpha 1-proteinase Inhibitor Deficiency
Intervention Biological: Alpha1- proteinase inhibitor [human]
Enrollment 140
Recruitment Details

This multicenter study was conducted at 22 centers in Europe, Canada, and Australia.

Alpha1-proteinase inhibitor (A1-PI) deficient individuals with emphysema, who had completed the 2-year treatment and observation periods in study CE1226_4001, except those participating in the USA, were invited to participate in study CE1226_3001.

Pre-assignment Details Subjects who had participated in the CE1226_4001 study, met the inclusion and exclusion criteria, and signed the informed consent were included in study CE1226_3001.
Arm/Group Title Zemaira®
Hide Arm/Group Description Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight administered intravenously once per week
Period Title: Overall Study
Started 140
Completed 131
Not Completed 9
Reason Not Completed
Drug abuse             1
Lung transplant             1
Travel/Vacation             1
Adverse event, serious fatal             1
Adverse Event             1
Withdrawal by Subject             4
Arm/Group Title Zemaira®
Hide Arm/Group Description Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight intravenously once per week
Overall Number of Baseline Participants 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants
<=18 years
0
   0.0%
Between 18 and 65 years
130
  92.9%
>=65 years
10
   7.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants
Female
61
  43.6%
Male
79
  56.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 140 participants
Canada 25
Sweden 17
Czech Republic 2
Romania 1
Ireland 19
Finland 3
Poland 4
Denmark 35
Australia 17
Germany 15
Estonia 2
1.Primary Outcome
Title Rate of Change of Adjusted Lung Density
Hide Description 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.
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.
Arm/Group Title Zemaira® (Early Start) Zemaira® (Delayed Start)
Hide Arm/Group Description:
Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
Overall Number of Participants Analyzed 75 64
Least Squares Mean (Standard Error)
Unit of Measure: g/L per year
TLC + FRC combined -1.632  (0.2824) -1.352  (0.2961)
TLC -1.627  (0.2743) -1.256  (0.2891)
FRC -1.658  (0.3186) -1.482  (0.3346)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zemaira® (Early Start), Zemaira® (Delayed Start)
Comments Analysis of the annual rate of change in lung density (for TLC + FRC combined) was a linear random regression model with country, inspiration state, time since Day 1 [CE1226_4001], and treatment-by time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.752
Comments A 1-sided P-value < 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% confidence interval [CI] being > zero) will indicate superiority of Early Start compared with Delayed Start.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value -0.279
Confidence Interval (2-Sided) 95%
-1.089 to 0.530
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zemaira® (Early Start), Zemaira® (Delayed Start)
Comments Analysis of the annual rate of change in lung density (for TLC) was a linear random regression model with country, time since Day 1 [CE1226_4001], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.823
Comments A 1-sided P-value < 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being > zero) will indicate superiority of Early Start compared with Delayed Start.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value -0.371
Confidence Interval (2-Sided) 95%
-1.159 to 0.417
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Zemaira® (Early Start), Zemaira® (Delayed Start)
Comments Analysis of the annual rate of change in lung density (for FRC) was a linear random regression model with country, time since Day 1 [CE1226_4001], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.648
Comments A 1-sided P-value < 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being > zero) will indicate superiority of Early Start compared with Delayed Start.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value -0.176
Confidence Interval (2-Sided) 95%
-1.09 to 0.738
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Absolute Change in Adjusted Lung Density
Hide Description 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.
Time Frame From baseline to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.
Arm/Group Title Zemaira® (Early Start) Zemaira® (Delayed Start)
Hide Arm/Group Description:
Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
Overall Number of Participants Analyzed 64 60
Least Squares Mean (Standard Error)
Unit of Measure: g/L
TLC + FRC combined, n = 64, 60 -3.031  (0.5888) -2.502  (0.6142)
TLC, n = 64, 59 -2.971  (0.5826) -2.485  (0.6142)
FRC, n = 64, 60 -2.934  (0.6671) -2.953  (0.6993)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zemaira® (Early Start), Zemaira® (Delayed Start)
Comments Analysis of the change in lung density (for TLC + FRC combined) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.526
Comments Two-sided P-value
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value -0.530
Confidence Interval (2-Sided) 95%
-2.179 to 1.120
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zemaira® (Early Start), Zemaira® (Delayed Start)
Comments Analysis of the change in lung density (for TLC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.558
Comments Two-sided P-value
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value -0.486
Confidence Interval (2-Sided) 95%
-2.126 to 1.154
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Zemaira® (Early Start), Zemaira® (Delayed Start)
Comments Analysis of the change in lung density (for FRC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.984
Comments Two-sided P-value
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value 0.019
Confidence Interval (2-Sided) 95%
-1.858 to 1.895
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change in Adjusted Lung Density
Hide Description 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.
Time Frame From baseline to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.
Arm/Group Title Zemaira® (Early Start) Zemaira® (Delayed Start)
Hide Arm/Group Description:
Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
Overall Number of Participants Analyzed 64 60
Mean (Standard Deviation)
Unit of Measure: Percent change from baseline
TLC and FRC combined, n = 64, 60 -6.741  (1.4031) -7.035  (1.4671)
TLC, n = 64, 59 -6.825  (1.4286) -6.674  (1.5061)
FRC, n = 64, 60 -6.494  (1.5027) -8.281  (1.5752)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zemaira® (Early Start), Zemaira® (Delayed Start)
Comments Analysis of the percent change in lung density (for TLC + FRC combined) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.883
Comments Two-sided P-value
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value 0.294
Confidence Interval (2-Sided) 95%
-3.645 to 4.233
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zemaira® (Early Start), Zemaira® (Delayed Start)
Comments Analysis of the percent change in lung density (for TLC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.941
Comments Two-sided P-value
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value -0.151
Confidence Interval (2-Sided) 95%
-4.172 to 3.870
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Zemaira® (Early Start), Zemaira® (Delayed Start)
Comments Analysis of the percent change in lung density (for FRC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.404
Comments Two-sided P-value
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value 1.787
Confidence Interval (2-Sided) 95%
-2.440 to 6.014
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Subject-reported Symptoms
Hide Description 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.
Time Frame From baseline to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.
Arm/Group Title Zemaira® (Early Start) Zemaira® (Delayed Start)
Hide Arm/Group Description:
Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
Overall Number of Participants Analyzed 67 58
Mean (Standard Deviation)
Unit of Measure: units on a scale (change from baseline)
Total score, n = 62, 56 1.185  (13.624) 1.499  (12.0507)
Symptoms score, n = 67, 58 6.601  (22.29) 0.728  (19.2189)
Activity score, n = 67, 57 0.55  (14.1429) 2.831  (14.0013)
Impact score, n = 65, 57 -0.22  (15.8999) 1.626  (13.5699)
5.Secondary Outcome
Title Percent Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1)
Hide Description [Not Specified]
Time Frame From baseline up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.
Arm/Group Title Zemaira® (Early Start) Zemaira® (Delayed Start)
Hide Arm/Group Description:
Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
Overall Number of Participants Analyzed 69 56
Mean (Standard Deviation)
Unit of Measure: Percent change from baseline
-8.610  (12.9541) -8.666  (10.9057)
6.Secondary Outcome
Title Percent Change in Lung Function as Measured by Ratio of FEV1/FVC (Forced Vital Capacity)
Hide Description [Not Specified]
Time Frame From baseline up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.
Arm/Group Title Zemaira® (Early Start) Zemaira® (Delayed Start)
Hide Arm/Group Description:
Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
Overall Number of Participants Analyzed 69 56
Mean (Standard Deviation)
Unit of Measure: Percent change from baseline
0.560  (12.9685) -5.441  (10.8993)
7.Secondary Outcome
Title Percent Change in Lung Function as Measured by Percent Predicted FEV1
Hide Description [Not Specified]
Time Frame From baseline up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.
Arm/Group Title Zemaira® (Early Start) Zemaira® (Delayed Start)
Hide Arm/Group Description:
Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
Overall Number of Participants Analyzed 68 54
Mean (Standard Deviation)
Unit of Measure: Percent change from baseline
-7.165  (13.2053) -6.958  (11.0846)
8.Secondary Outcome
Title Number of Subjects With Pulmonary Exacerbations
Hide Description [Not Specified]
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Zemaira® (Early Start) Zemaira® (Delayed Start)
Hide Arm/Group Description:
Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
Overall Number of Participants Analyzed 76 64
Measure Type: Number
Unit of Measure: participants
No exacerbation 13 16
Overall (at least 1 exacerbation) 63 48
Moderate exacerbation 60 46
Severe exacerbation 17 11
Neither moderate or severe exacerbation 21 17
9.Secondary Outcome
Title Annual Rate in Subject Years of Pulmonary Exacerbations
Hide Description Annual exposure‑adjusted incidence rate of pulmonary exacerbations.
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Zemaira® (Early Start) Zemaira® (Delayed Start)
Hide Arm/Group Description:
Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
Overall Number of Participants Analyzed 76 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Exacerbations/subject year
1.71
(1.49 to 1.92)
1.39
(1.18 to 1.59)
10.Secondary Outcome
Title Time to First Pulmonary Exacerbation
Hide Description [Not Specified]
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Zemaira® (Early Start) Zemaira® (Delayed Start)
Hide Arm/Group Description:
Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
Overall Number of Participants Analyzed 76 64
Median (95% Confidence Interval)
Unit of Measure: years
0.405
(0.315 to 0.687)
0.602
(0.287 to 0.843)
11.Secondary Outcome
Title Percentage of Subjects With Treatment Emergent Adverse Events
Hide Description 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.
Time Frame From baseline up to 2.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population comprises all subjects who were included in the study and who received at least 1 dose of Zemaira during study CE1226_3001.
Arm/Group Title Zemaira® (Early Start) Zemaira® (Delayed Start)
Hide Arm/Group Description:
Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
Overall Number of Participants Analyzed 76 64
Measure Type: Number
Unit of Measure: percentage of subjects
Any TEAE 100 96.9
Mild TEAE 19.7 15.6
Moderate TEAE 50.0 51.6
Severe TEAE 30.3 29.7
Any treatment related TEAE 14.5 10.9
Any serious TEAE 36.8 35.9
Any TEAE within 24 hours 86.8 79.7
Time Frame Up to 2.5 years
Adverse Event Reporting Description Treatment-emergent adverse events are presented
 
Arm/Group Title Zemaira®
Hide Arm/Group Description The safety population comprised all subjects enrolled in study CE1226_3001 and who received at least 1 administration of Zemaira® during study CE1226_3001.
All-Cause Mortality
Zemaira®
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zemaira®
Affected / at Risk (%) # Events
Total   51/140 (36.43%)    
Cardiac disorders   
Palpitations  1  2/140 (1.43%)  4
Angina unstable  1  1/140 (0.71%)  1
Cardiac failure  1  1/140 (0.71%)  2
Gastrointestinal disorders   
Abdominal pain  1  1/140 (0.71%)  1
Abdominal wall haematoma  1  1/140 (0.71%)  1
Diarrhoea  1  1/140 (0.71%)  1
Enterocolitis  1  1/140 (0.71%)  1
Haemorrhoidal haemorrhage  1  1/140 (0.71%)  1
Ileus  1  1/140 (0.71%)  1
Inguinal hernia  1  1/140 (0.71%)  1
Melaena  1  1/140 (0.71%)  1
Nausea  1  1/140 (0.71%)  1
Pancreatitis  1  1/140 (0.71%)  1
Vomiting  1  1/140 (0.71%)  1
General disorders   
Condition aggravated  1  3/140 (2.14%)  4
Chest pain  1  1/140 (0.71%)  1
Infections and infestations   
Pneumonia  1  6/140 (4.29%)  6
Lower respiratory tract infection  1  4/140 (2.86%)  8
Infective exacerbation of chronic obstructive airways disease  1  2/140 (1.43%)  2
Anal abscess  1  1/140 (0.71%)  1
Diverticulitis  1  1/140 (0.71%)  1
Herpes zoster  1  1/140 (0.71%)  1
Influenza  1  1/140 (0.71%)  1
Lung abscess  1  1/140 (0.71%)  1
Meningitis  1  1/140 (0.71%)  1
Pneumonia bacterial  1  1/140 (0.71%)  1
Upper respiratory tract infection  1  1/140 (0.71%)  1
Injury, poisoning and procedural complications   
Humerus fracture  1  1/140 (0.71%)  1
Infusion related reaction  1  1/140 (0.71%)  1
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion  1  2/140 (1.43%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma  1  1/140 (0.71%)  1
Nervous system disorders   
Transient ischaemic attack  1  2/140 (1.43%)  2
Cerebral thrombosis  1  1/140 (0.71%)  1
Dizziness  1  1/140 (0.71%)  1
Hypotonia  1  1/140 (0.71%)  1
Lumbar radiculopathy  1  1/140 (0.71%)  1
Syncope  1  1/140 (0.71%)  1
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  17/140 (12.14%)  43
Pneumothorax  1  2/140 (1.43%)  2
Bronchiectasis  1  1/140 (0.71%)  1
Dyspnoea  1  1/140 (0.71%)  1
Nocturnal dyspnoea  1  1/140 (0.71%)  1
Pulmonary embolism  1  1/140 (0.71%)  1
Pulmonary fibrosis  1  1/140 (0.71%)  1
Surgical and medical procedures   
Hysterectomy  1  1/140 (0.71%)  1
Lung transplant  1  1/140 (0.71%)  1
Strangulated hernia repair  1  1/140 (0.71%)  1
Vascular disorders   
Deep vein thrombosis  1  1/140 (0.71%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zemaira®
Affected / at Risk (%) # Events
Total   137/140 (97.86%)    
Gastrointestinal disorders   
Diarrhoea  1  11/140 (7.86%)  11
Nausea  1  10/140 (7.14%)  11
General disorders   
Condition aggravated  1  27/140 (19.29%)  71
Oedema peripheral  1  12/140 (8.57%)  13
Pyrexia  1  10/140 (7.14%)  15
Infections and infestations   
Nasopharyngitis  1  40/140 (28.57%)  72
Lower respiratory tract infection  1  20/140 (14.29%)  106
Upper respiratory tract infection  1  16/140 (11.43%)  37
Influenza  1  15/140 (10.71%)  17
Oral candidiasis  1  13/140 (9.29%)  37
Bronchitis  1  12/140 (8.57%)  22
Pneumonia  1  10/140 (7.14%)  17
Sinusitis  1  8/140 (5.71%)  15
Urinary tract infection  1  8/140 (5.71%)  14
Musculoskeletal and connective tissue disorders   
Back pain  1  15/140 (10.71%)  19
Nervous system disorders   
Headache  1  28/140 (20.00%)  58
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  50/140 (35.71%)  137
Oropharyngeal pain  1  19/140 (13.57%)  21
Dyspnoea  1  17/140 (12.14%)  40
Cough  1  15/140 (10.71%)  27
Indicates events were collected by systematic assessment
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Term from vocabulary, MedDRA (15.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Clinical Trial Disclosure Manager
Organization: CSL Behring
Phone: Use Email contact
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00670007     History of Changes
Other Study ID Numbers: CE1226_3001
1466 ( Other Identifier: CSL Behring )
2007-007129-38 ( EudraCT Number )
First Submitted: April 29, 2008
First Posted: May 1, 2008
Results First Submitted: June 2, 2016
Results First Posted: July 12, 2016
Last Update Posted: August 15, 2016