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Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency

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ClinicalTrials.gov Identifier: NCT00261833
Recruitment Status : Completed
First Posted : December 5, 2005
Results First Posted : January 19, 2015
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Alpha1-proteinase Inhibitor Deficiency
Emphysema
Interventions Biological: Alpha1-proteinase inhibitor
Other: Placebo
Enrollment 180
Recruitment Details This multicenter, multinational study enrolled participants at 28 study centers in Europe, North America, and Australia.
Pre-assignment Details Screening took place 1 to 4 weeks prior to the first dose of randomized investigational product (ie, either Zemaira® or placebo). A total of 208 participants were screened; 28 of these did not fulfill all eligibility criteria and were therefore screening failures.
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous Lyophilized preparation: 60 mg/kg body weight/week intravenous
Period Title: Overall Study
Started 93 87
Completed 84 69
Not Completed 9 18
Reason Not Completed
Death             1             3
Adverse Event             1             4
Withdrawal by Subject             5             7
Protocol Violation             0             1
Suspicion of pulmonary cancer             0             1
Lung transplantation             1             1
Missing reason             1             0
Not interested in being participant             0             1
Arm/Group Title Zemaira® Placebo Total
Hide Arm/Group Description Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous Lyophilized preparation: 60 mg/kg body weight/week intravenous Total of all reporting groups
Overall Number of Baseline Participants 93 87 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants 87 participants 180 participants
53.81  (6.193) 52.40  (7.812) 53.13  (7.374)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 87 participants 180 participants
Female
45
  48.4%
37
  42.5%
82
  45.6%
Male
48
  51.6%
50
  57.5%
98
  54.4%
Baseline percent predicted forced expiratory volume in 1 second (FEV1)  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 93 participants 87 participants 180 participants
47.4  (12.1) 47.2  (11.1) 47.3  (11.6)
Baseline diffusion capacity of carbon monoxide (DLCO)  
Mean (Standard Deviation)
Unit of measure:  mL/min/mmHg
Number Analyzed 93 participants 87 participants 180 participants
13.6  (5.3) 15.0  (5.6) 14.3  (5.5)
Number of participants with ZZ genotype (A1-PI deficiency), or SZ, Z / Null or Other genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 93 participants 87 participants 180 participants
ZZ 83 83 166
SZ 2 0 2
Z / Null 2 1 3
Other 6 3 9
1.Primary Outcome
Title Annual Rate of Change in Lung Density
Hide Description As measured by centralized, standardized computer tomographic (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 rate of decline in each treatment group.
Time Frame Over a 2-year period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with at least 1 valid CT scan.
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description:
Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Lyophilized preparation: 60 mg/kg body weight/week intravenous
Overall Number of Participants Analyzed 92 85
Least Squares Mean (Standard Error)
Unit of Measure: g/L per year
TLC + FRC combined -1.50  (0.22) -2.12  (0.24)
TLC -1.45  (0.23) -2.19  (0.25)
FRC -1.55  (0.24) -2.02  (0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zemaira®, Placebo
Comments Analysis of the annual rate of change in lung density (TLC+FRC combined) was a linear mixed model with country, inspiration state, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-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 0.029
Comments A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira minus placebo (ie, the lower bound of the 95% confidence interval [CI] being greater than zero) will indicate superiority of Zemaira compared with Placebo.
Method 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value 0.618
Confidence Interval (2-Sided) 95%
-0.024 to 1.261
Estimation Comments A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zemaira®, Placebo
Comments Analysis of the annual rate of change in lung density (TLC) was a linear mixed model with country, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-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 0.017
Comments A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.
Method 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value 0.740
Confidence Interval (2-Sided) 95%
0.059 to 1.420
Estimation Comments A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Zemaira®, Placebo
Comments Analysis of the annual rate of change in lung density (FRC) was a linear mixed model with country, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-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 0.090
Comments A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.
Method 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value 0.478
Confidence Interval (2-Sided) 95%
-0.223 to 1.180
Estimation Comments A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.
2.Secondary Outcome
Title Annual Rate of Pulmonary Exacerbations
Hide Description Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion. The annual rate was based on the total number of exacerbations and the total number of participant study days for all participants in the specified analysis population and adjusted to 365.25 days.
Time Frame Over a 2-year period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with A1-PI deficiency who were included in the study and randomized.
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description:
Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Lyophilized preparation: 60 mg/kg body weight/week intravenous
Overall Number of Participants Analyzed 93 87
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: exacerbations per participant year
1.70
(1.51 to 1.89)
1.42
(1.23 to 1.61)
3.Secondary Outcome
Title Percent Change in FEV1
Hide Description Percent change from baseline to Month 24.
Time Frame From baseline to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description:
Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Lyophilized preparation: 60 mg/kg body weight/week intravenous
Overall Number of Participants Analyzed 89 84
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-4.29  (1.26) -2.06  (1.30)
4.Secondary Outcome
Title Time to First Pulmonary Exacerbation
Hide Description Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.
Time Frame Over a 2-year period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with A1-PI deficiency who were included in the study and randomized.
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description:
Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Lyophilized preparation: 60 mg/kg body weight/week intravenous
Overall Number of Participants Analyzed 93 87
Median (95% Confidence Interval)
Unit of Measure: Years
0.60
(0.33 to 1.11)
0.73
(0.46 to 1.17)
5.Secondary Outcome
Title Change in Lung Density
Hide Description Change from baseline to Month 24 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.
Time Frame From baseline to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least 1 endpoint assessment available.
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description:
Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Lyophilized preparation: 60 mg/kg body weight/week intravenous
Overall Number of Participants Analyzed 80 67
Least Squares Mean (Standard Error)
Unit of Measure: g/L
TLC + FRC combined -2.33  (0.45) -3.37  (0.50)
TLC (N=66 for placebo) -2.22  (0.47) -3.54  (0.52)
FRC -2.44  (0.50) -3.33  (0.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zemaira®, Placebo
Comments Analysis of the change in lung density (TLC+FRC combined) from baseline to Month 24 was a mixed effects analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect 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 0.058
Comments A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.
Method 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
-0.26 to 2.34
Estimation Comments A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zemaira®, Placebo
Comments Analysis of the change in lung density (TLC) from baseline to Month 24 was a mixed effects ANCOVA model with country, treatment, and baseline lung density as fixed effects 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 0.028
Comments A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (i.e., the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.
Method 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
-0.03 to 2.67
Estimation Comments A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Zemaira®, Placebo
Comments Analysis of the change in lung density (FRC) from baseline to Month 24 was a mixed effects ANCOVA model with country, treatment, and baseline lung density as fixed effects as a repeated random effect 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 0.115
Comments A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.
Method 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in lung density(adjusted P15)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
-0.57 to 2.34
Estimation Comments A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.
6.Secondary Outcome
Title Change in Exercise Capacity
Hide Description Exercise capacity was measured as distance walked, using the incremental shuttle walk test. Change from baseline to end of treatment (2 years) in exercise capacity was analysed using an analysis of covariance (ANCOVA).
Time Frame From baseline to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description:
Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Lyophilized preparation: 60 mg/kg body weight/week intravenous
Overall Number of Participants Analyzed 89 82
Least Squares Mean (Standard Error)
Unit of Measure: metre
1.77  (13.0) 14.86  (13.5)
7.Secondary Outcome
Title Change in Patient-reported Symptoms
Hide Description Patient-reported symptoms were measured using the symptoms score component of the St George's Respiratory Questionnaire (SGRQ). SGRQ scores range from 0 to 100, with higher scores indicating more limitations and negative values for change indicating improvement. Change from baseline to end of treatment (2 years) in SGRQ was analysed using an ANCOVA.
Time Frame From baseline to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description:
Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Lyophilized preparation: 60 mg/kg body weight/week intravenous
Overall Number of Participants Analyzed 85 73
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.19  (1.79) -0.09  (1.93)
8.Secondary Outcome
Title Frequency and Intensity of Adverse Events (AEs)
Hide Description Number of participants with at least one AE, and the number of participants with mild, moderate or severe AEs. AE intensity was defined as mild (does not interfere with routine activities), moderate (interferes with routine activities), or severe (impossible to perform routine activities).
Time Frame Over a 2-year period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least 1 infusion of either Zemaira® or placebo.
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description:
Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Lyophilized preparation: 60 mg/kg body weight/week intravenous
Overall Number of Participants Analyzed 93 87
Measure Type: Number
Unit of Measure: participants
At least 1 AE 92 86
Mild AEs 13 16
Moderate AEs 54 43
Severe AEs 25 27
9.Secondary Outcome
Title Percent Change in Percent Predicted FEV1
Hide Description Percent change from baseline to Month 24.
Time Frame From baseline to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description:
Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Lyophilized preparation: 60 mg/kg body weight/week intravenous
Overall Number of Participants Analyzed 89 84
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-4.16  (1.27) -1.90  (1.31)
10.Secondary Outcome
Title Percent Change in FEV1 Divided by Forced Vital Capacity
Hide Description Percent change from baseline to Month 24.
Time Frame From baseline to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description:
Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Lyophilized preparation: 60 mg/kg body weight/week intravenous
Overall Number of Participants Analyzed 89 84
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-2.68  (1.36) 1.56  (1.40)
11.Secondary Outcome
Title Percent Change in DLCO
Hide Description Percent change from baseline to Month 24.
Time Frame From baseline to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description:
Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Lyophilized preparation: 60 mg/kg body weight/week intravenous
Overall Number of Participants Analyzed 89 84
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-3.16  (1.96) -1.85  (2.03)
12.Secondary Outcome
Title Duration of Pulmonary Exacerbations Relative to Treatment Duration
Hide Description Defined as the percentage of total treatment duration across participants for 1) exacerbations overall, 2) antibiotic treatment for exacerbations, and 3) hospitalization for exacerbations. Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.
Time Frame Over a 2-year period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with A1-PI deficiency who were included in the study and randomized.
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description:
Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Lyophilized preparation: 60 mg/kg body weight/week intravenous
Overall Number of Participants Analyzed 93 87
Mean (Standard Deviation)
Unit of Measure: percentage of total treatment duration
Exacerbations (n = 68, 59) 77.2  (98.8) 58.9  (109.1)
Antibiotic treatment (n = 59, 52) 6.32  (6.75) 5.55  (6.80)
Hospitalization (n = 19, 16) 6.22  (8.79) 2.16  (1.67)
13.Secondary Outcome
Title Severity of Pulmonary Exacerbations
Hide Description

Defined as the number of participants requiring 1) antibiotic treatment for exacerbations, and 2) hospitalization for exacerbations. Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.

Antibiotic treatment usage was reported by quarterly interval.

Time Frame Over a 2-year period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with A1-PI deficiency who were included in the study and randomized.
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description:
Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Lyophilized preparation: 60 mg/kg body weight/week intravenous
Overall Number of Participants Analyzed 93 87
Measure Type: Number
Unit of Measure: participants
Total hospitalizations 13 9
0 hospitalizations 80 78
1 hospitalization 10 5
2 hospitalizations 1 1
3 hospitalizations 1 3
>3 hospitalizations 1 0
Antibiotics: Day 1 to <Month 3 22 19
Antibiotics: Month 3 to <Month 6 29 20
Antibiotics: Month 6 to <Month 9 24 15
Antibiotics: Month 9 to <Month 12 21 17
Antibiotics: Month 12 to <Month 15 30 21
Antibiotics: Month 15 to <Month 18 21 15
Antibiotics: Month 18 to <Month 21 26 15
Antibiotics: Month 21 to <Month 24 20 15
14.Other Pre-specified Outcome
Title Baseline Lung Density at Total Lung Capacity (TLC) and Forced Residual Capacity (FRC)
Hide Description [Not Specified]
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description:
Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Placebo: Lyophilized preparation: 60 mg/kg body weight/week intravenous
Overall Number of Participants Analyzed 90 83
Mean (Standard Deviation)
Unit of Measure: g/L
TLC 45.5  (15.8) 48.9  (15.5)
FRC 47.6  (15.7) 50.7  (15.0)
Time Frame For the duration of the study (25 months; 1 month screening period, 24 months treatment period).
Adverse Event Reporting Description The randomized, double-blind investigational product (Zemaira® or placebo) was administered as 60 mg once per week for 24 months. In exceptional cases, a dose of 120 mg could be given to cover a 2-week period. The safety population comprised all participants receiving at least 1 infusion of either Zemaira® or placebo.
 
Arm/Group Title Zemaira® Placebo
Hide Arm/Group Description Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous Lyophilized preparation: 60 mg/kg body weight/week intravenous
All-Cause Mortality
Zemaira® Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zemaira® Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/93 (30.11%)      28/87 (32.18%)    
Cardiac disorders     
Angina pectoris  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Palpitations  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Eye disorders     
Eye inflammation  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Gastroesophageal reflux disease  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Ileus  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Intestinal obstruction  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Nausea  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Small intestinal obstruction  1  1/93 (1.08%)  1 0/87 (0.00%)  0
General disorders     
Adhesion  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Chest pain  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Condition aggravated  1  1/93 (1.08%)  2 0/87 (0.00%)  0
Influenza like illness  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Pyrexia  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Immune system disorders     
Anaphylactic reaction  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Infections and infestations     
Pneumonia  1  3/93 (3.23%)  3 4/87 (4.60%)  6
Lower respiratory tract infection  1  1/93 (1.08%)  1 4/87 (4.60%)  5
Diverticulitis  1  1/93 (1.08%)  1 2/87 (2.30%)  2
Bronchitis  1  1/93 (1.08%)  1 1/87 (1.15%)  1
Appendicitis  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Cellulitis  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Gastroenteritis viral  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Graft infection  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Pyelonephritis  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Sepsis  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Urinary tract infection  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Injury, poisoning and procedural complications     
Joint injury  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Post procedural haemorrhage  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Metabolism and nutrition disorders     
Hyponatraemia  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  1/93 (1.08%)  1 1/87 (1.15%)  1
Intervertebral disc protrusion  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Muscle spasms  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Musculoskeletal chest pain  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm  1  2/93 (2.15%)  2 1/87 (1.15%)  1
Bladder cancer  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Breast cancer  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Breast cancer metastatic  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Lung neoplasm malignant  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Parathyroid tumour benign  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Nervous system disorders     
Dizziness  1  1/93 (1.08%)  2 0/87 (0.00%)  0
Neuropathy peripheral  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Syncope  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Psychiatric disorders     
Confusional state  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Suicide attempt  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Renal and urinary disorders     
Hydronephrosis  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Nephrolithiasis  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  9/93 (9.68%)  18 2/87 (2.30%)  3
Dyspnoea  1  1/93 (1.08%)  2 2/87 (2.30%)  2
Pneumothorax  1  2/93 (2.15%)  2 1/87 (1.15%)  2
Pulmonary embolism  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Respiratory failure  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Surgical and medical procedures     
Aortic aneurysm repair  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Tonsillectomy  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Transurethral prostatectomy  1  1/93 (1.08%)  1 0/87 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  0/93 (0.00%)  0 1/87 (1.15%)  1
Hypotension  1  1/93 (1.08%)  1 0/87 (0.00%)  0
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® Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   90/93 (96.77%)      84/87 (96.55%)    
Gastrointestinal disorders     
Nausea  1  14/93 (15.05%)  22 8/87 (9.20%)  11
Abdominal pain upper  1  9/93 (9.68%)  11 6/87 (6.90%)  11
Diarrhoea  1  8/93 (8.60%)  9 7/87 (8.05%)  9
Toothache  1  5/93 (5.38%)  7 9/87 (10.34%)  10
Gastrooesophageal reflux disease  1  5/93 (5.38%)  5 5/87 (5.75%)  5
Vomiting  1  5/93 (5.38%)  10 5/87 (5.75%)  6
Abdominal discomfort  1  2/93 (2.15%)  2 6/87 (6.90%)  8
Gastritis  1  6/93 (6.45%)  9 1/87 (1.15%)  2
General disorders     
Condition aggravated  1  20/93 (21.51%)  62 14/87 (16.09%)  41
Fatigue  1  8/93 (8.60%)  14 10/87 (11.49%)  12
Pyrexia  1  12/93 (12.90%)  14 6/87 (6.90%)  8
Oedema peripheral  1  6/93 (6.45%)  6 10/87 (11.49%)  14
Influenza like illness  1  4/93 (4.30%)  5 5/87 (5.75%)  5
Chest pain  1  5/93 (5.38%)  5 1/87 (1.15%)  1
Infections and infestations     
Nasopharyngitis  1  30/93 (32.26%)  54 26/87 (29.89%)  61
Lower respiratory tract infection  1  18/93 (19.35%)  88 17/87 (19.54%)  68
Upper respiratory tract infection  1  15/93 (16.13%)  28 14/87 (16.09%)  26
Influenza  1  14/93 (15.05%)  14 10/87 (11.49%)  12
Sinusitis  1  12/93 (12.90%)  17 11/87 (12.64%)  19
Bronchitis  1  12/93 (12.90%)  25 10/87 (11.49%)  15
Pneumonia  1  8/93 (8.60%)  12 10/87 (11.49%)  19
Urinary tract infection  1  8/93 (8.60%)  12 6/87 (6.90%)  9
Gastroenteritis  1  4/93 (4.30%)  5 6/87 (6.90%)  6
Rhinitis  1  7/93 (7.53%)  8 3/87 (3.45%)  3
Pharyngitis  1  4/93 (4.30%)  5 5/87 (5.75%)  8
Respiratory tract infection  1  1/93 (1.08%)  2 8/87 (9.20%)  12
Tooth abscess  1  1/93 (1.08%)  1 5/87 (5.75%)  5
Injury, poisoning and procedural complications     
Contusion  1  0/93 (0.00%)  0 5/87 (5.75%)  5
Musculoskeletal and connective tissue disorders     
Back pain  1  11/93 (11.83%)  11 9/87 (10.34%)  11
Arthralgia  1  6/93 (6.45%)  9 6/87 (6.90%)  9
Muscle spasms  1  7/93 (7.53%)  10 4/87 (4.60%)  7
Musculoskeletal pain  1  5/93 (5.38%)  5 4/87 (4.60%)  8
Pain in extremity  1  5/93 (5.38%)  6 4/87 (4.60%)  5
Nervous system disorders     
Headache  1  38/93 (40.86%)  101 34/87 (39.08%)  108
Dizziness  1  6/93 (6.45%)  13 8/87 (9.20%)  8
Psychiatric disorders     
Anxiety  1  5/93 (5.38%)  12 4/87 (4.60%)  4
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  27/93 (29.03%)  93 19/87 (21.84%)  53
Oropharyngeal pain  1  22/93 (23.66%)  36 10/87 (11.49%)  13
Cough  1  21/93 (22.58%)  33 8/87 (9.20%)  9
Dyspnoea  1  16/93 (17.20%)  28 8/87 (9.20%)  9
Vascular disorders     
Hypertension  1  6/93 (6.45%)  6 10/87 (11.49%)  10
Indicates events were collected by systematic assessment
1
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: NCT00261833     History of Changes
Other Study ID Numbers: CE1226_4001
1449 ( Other Identifier: CSL Behring )
2005-003459-12 ( EudraCT Number )
First Submitted: December 2, 2005
First Posted: December 5, 2005
Results First Submitted: November 2, 2014
Results First Posted: January 19, 2015
Last Update Posted: January 19, 2015