We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00997204
Recruitment Status : Completed
First Posted : October 19, 2009
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hereditary Angioedema
Intervention: Drug: Icatibant

  Participant Flow

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
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 
[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 
[1] 1 subject did not self-administered icatibant but had a HCP to perform. the data were not included.

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 79   25   104 
[Units: Years]
Mean (Standard Deviation)
 40.607  (13.044)   44.68  (16.53)   41.58  (13.98) 
[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

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

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
No text entered.

  More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00997204     History of Changes
Other Study ID Numbers: JE049-3101
2008-000071-25 ( EudraCT Number )
First Submitted: October 16, 2009
First Posted: October 19, 2009
Results First Submitted: November 4, 2013
Results First Posted: July 28, 2014
Last Update Posted: July 28, 2014