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Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert

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ClinicalTrials.gov Identifier: NCT01467947
Recruitment Status : Completed
First Posted : November 9, 2011
Results First Posted : November 16, 2015
Last Update Posted : February 6, 2017
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
Condition Hereditary Angioedema Types I and II
Intervention Biological: Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection
Enrollment 46
Recruitment Details  
Pre-assignment Details 60 subjects were screened and enrolled in the study. 14 subjects did not experience an HAE attack before the study ended and so did not receive study treatment. 46 subjects started and completed the active treatment period of the study.
Arm/Group Title C1 Esterase Inhibitor
Hide Arm/Group Description Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
Period Title: Overall Study
Started 46
Completed 46
Not Completed 0
Arm/Group Title C1 Esterase Inhibitor
Hide Arm/Group Description Subjects received 20 IU/kg C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
<=18 years
2
   4.3%
Between 18 and 65 years
42
  91.3%
>=65 years
2
   4.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants
38.9  (14.42)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
32
  69.6%
Male
14
  30.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants
Romania 15
Hungary 8
Poland 13
Bulgaria 10
1.Primary Outcome
Title Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies
Hide Description Subjects with no positive baseline result and at least one positive post-baseline result for inhibitory anti-C1-INH antibodies.
Time Frame Baseline to approximately 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1 Esterase Inhibitor
Hide Arm/Group Description:
Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: subjects
0
2.Secondary Outcome
Title Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies
Hide Description Subjects with at least one positive result for inhibitory or non-inhibitory anti-C1-INH antibodies.
Time Frame Baseline to approximately 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C1 Esterase Inhibitor
Hide Arm/Group Description:
Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: Subjects
Antibodies detected on Day 1 (Baseline) 9
Antibodies detected post-baseline 10
Antibodies first detected at Month 3 2
Antibodies first detected at Month 6 1
Antibodies first detected at Month 9 1
Time Frame Baseline to approximately 9 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title C1 Esterase Inhibitor
Hide Arm/Group Description Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
All-Cause Mortality
C1 Esterase Inhibitor
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
C1 Esterase Inhibitor
Affected / at Risk (%) # Events
Total   2/46 (4.35%)    
Congenital, familial and genetic disorders   
Hereditary angioedema  1  1/46 (2.17%)  1
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous  1  1/46 (2.17%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
C1 Esterase Inhibitor
Affected / at Risk (%) # Events
Total   7/46 (15.22%)    
Nervous system disorders   
Headache  1  6/46 (13.04%)  26
Vascular disorders   
Hypotension  1  3/46 (6.52%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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
Layout table for Results Point of Contact information
Name/Title: Program Director, Clinical R&D
Organization: CSL Behring
Phone: Use email contact
EMail: clinicaltrials@cslbehring.com
Layout table for additonal information
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01467947     History of Changes
Other Study ID Numbers: CE1145_4001
2010-024242-30 ( EudraCT Number )
First Submitted: November 7, 2011
First Posted: November 9, 2011
Results First Submitted: October 16, 2015
Results First Posted: November 16, 2015
Last Update Posted: February 6, 2017