Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00097695
First received: November 26, 2004
Last updated: May 22, 2014
Last verified: May 2014
Results First Received: January 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Angioedema
Interventions: Drug: Icatibant
Drug: Placebo

  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 must have an eligible HAE attack to be randomized.64 patients were in the controlled phase(27icatibant,29 placebo,8subjects with laryngeal attacks were treated with open label icatibant).A total of 72 were treated in the open label phase(20 entered directly into the OLE phase+ 52 from the controlled phase).

Reporting Groups
  Description
Randomized -Icatibant Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
Randomized -Placebo Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
Controlled Open-label / Laryngeal Attack Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
Untreated Patients at the Baseline Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.

Participant Flow for 2 periods

Period 1:   The Controlled Phase
    Randomized -Icatibant     Randomized -Placebo     Controlled Open-label / Laryngeal Attack     Untreated Patients at the Baseline  
STARTED     27     29     8     20  
COMPLETED     23     26     3     0 [1]
NOT COMPLETED     4     3     5     20  
[1] Patients screened and found eligible but did not have HAE attack or attack was not severe enough

Period 2:   The Open Label Extension (OLE) Phase
    Randomized -Icatibant     Randomized -Placebo     Controlled Open-label / Laryngeal Attack     Untreated Patients at the Baseline  
STARTED     23     26     3     20  
COMPLETED     10     11     1     15  
NOT COMPLETED     13     15     2     5  



  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
Randomized -Icatibant Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
Randomized -Placebo Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
Controlled Open-label / Laryngeal Attack patients who received first treatment Open-Label due to laryngeal symptoms
Untreated Patients at the Baseline Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
Total Total of all reporting groups

Baseline Measures
    Randomized -Icatibant     Randomized -Placebo     Controlled Open-label / Laryngeal Attack     Untreated Patients at the Baseline     Total  
Number of Participants  
[units: participants]
  27     29     8     20     84  
Age  
[units: Years]
Mean ± Standard Deviation
  34.8  ± 9.81     34.9  ± 11.37     47.1  ± 13.86     37.4  ± 11.48     36.6  ± 11.5  
Gender  
[units: Participants]
         
Female     16     21     5     15     57  
Male     11     8     3     5     27  



  Outcome Measures
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1.  Primary:   Time to Onset of Symptom Relief (TOSR)   [ Time Frame: 5 days ]

2.  Secondary:   Time to Regression (Start of Improvement) According to Patient   [ Time Frame: 5 days ]

3.  Secondary:   Time to Almost Complete Symptom Relief   [ Time Frame: 5 days ]


  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
No text entered.


  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: NCT00097695     History of Changes
Other Study ID Numbers: JE049 #2103, FAST1
Study First Received: November 26, 2004
Results First Received: January 24, 2011
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada