EASSI - Evaluation of the Safety of Self-Administration With Icatibant

This study has been completed.
Sponsor:
Collaborator:
Jerini AG
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00997204
First received: October 16, 2009
Last updated: June 30, 2014
Last verified: June 2014
Results First Received: November 4, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hereditary Angioedema
Intervention: Drug: Icatibant

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened for entry based on their known medical histories (HAE attacks) and previous exposure to a treatment (naïve or not). 151 were enrolled and trained in the self-administration. 47 of these subjects did not have an acute attack of HAE treated with icatibant during this study and were included in the untreated population.

Reporting Groups
  Description
Naive Subjects/ Naive Treatment Phase Patients who had never received icatibant before this phase, got treatment of Acute HAE Attack with SC icatibant (30 mg)Administered at Site by Health Care Provider.
Non-Naive Subjects/ Self-administration Phase Subjects who had received treatment for HAE with icatibant in previous clinical trials or had been previously treated with the marketed product Firazyr®, got Treatment of Acute HAE Attack with SC icatibant (30 mg)Self-Administered.

Participant Flow for 2 periods

Period 1:   Naive Treatment Phase
    Naive Subjects/ Naive Treatment Phase     Non-Naive Subjects/ Self-administration Phase  
STARTED     25     79 [1]
COMPLETED     19     0  
NOT COMPLETED     6     79  
[1] Non-naive patients participated in the study but they were not treated in the naive treatment phase

Period 2:   Self-administration Phase
    Naive Subjects/ Naive Treatment Phase     Non-Naive Subjects/ Self-administration Phase  
STARTED     19     78 [1]
COMPLETED     19     77  
NOT COMPLETED     0     1  
[1] 1 subject did not self-administered icatibant but had a HCP to perform. the data were not included.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Non-Naive Patients Patients who previously treated with icatibant in clinical studies or with commercial Firazyr® and got the treatment during the self-administered phase
Naive Patients Patients who had never received icatibant and treated in both the Naive treatment phase and the Self-administered phase
Total Total of all reporting groups

Baseline Measures
    Non-Naive Patients     Naive Patients     Total  
Number of Participants  
[units: participants]
  79     25     104  
Age  
[units: years]
Mean ± Standard Deviation
  40.607  ± 13.044     44.68  ± 16.53     41.58  ± 13.98  
Gender  
[units: participants]
     
Female     52     16     68  
Male     27     9     36  
Region of Enrollment  
[units: participants]
     
France     6     0     6  
Argentina     18     5     23  
Spain     9     2     11  
Denmark     5     0     5  
Austria     9     5     14  
Israel     15     0     15  
Germany     9     5     14  
Italy     1     1     2  
Switzerland     1     1     2  
United Kingdom     6     6     12  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant   [ Time Frame: 7 days from the beginning of each phase ]

2.  Secondary:   Clinical Efficacy of Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant, Time to Symptom Relief Using VAS Score for a Single Primary Symptom by Patient Cohort   [ Time Frame: 48 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Alan Kimura, MD,PhD
Organization: Shire Human Genetic Therapies, Inc
phone: 781-482-0738
e-mail: akimura@shire.com


No publications provided by Shire

Publications automatically indexed to this study:

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00997204     History of Changes
Other Study ID Numbers: JE049-3101, 2008-000071-25
Study First Received: October 16, 2009
Results First Received: November 4, 2013
Last Updated: June 30, 2014
Health Authority: Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ethics Commission
Switzerland: Swissmedic
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Denmark: Danish Medicines Agency