Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE) (FAST2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00500656
First received: July 12, 2007
Last updated: June 25, 2014
Last verified: May 2014
Results First Received: October 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hereditary Angioedema
Interventions: Drug: Icatibant
Drug: Tranexamic Acid
Drug: Oral Placebo
Drug: S.C. 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
85 patients participated in the study(36 in the icatibant group and 38 in the tranexamic acid group)3 patients with laryngeal symptoms at Baseline.8 Patients 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

Reporting Groups
  Description
Randomized Controlled -Icatibant Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
Randomized Controlled-Tranexamic Acid Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) 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 were treated in the open label phase with icatibant

Participant Flow for 2 periods

Period 1:   Controlled Phase
    Randomized Controlled -Icatibant     Randomized Controlled-Tranexamic Acid     Controlled Open-label / Laryngeal Attack     Untreated Patients at the Baseline  
STARTED     36     38     3     8  
COMPLETED     26     28     2     0  
NOT COMPLETED     10     10     1     8  

Period 2:   Open Label Extension (OLE) Phase
    Randomized Controlled -Icatibant     Randomized Controlled-Tranexamic Acid     Controlled Open-label / Laryngeal Attack     Untreated Patients at the Baseline  
STARTED     23 [1]   21 [2]   2     8 [3]
COMPLETED     16     9     1     6  
NOT COMPLETED     7     12     1     2  
[1] 3 Subjects did not experience an angioedema attack after their first attack in the controlled phase
[2] 7 Subjects did not experience an angioedema attack after their first attack in the controlled phase
[3] Subjects did not experience an angioedema attack during the controlled phase



  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 Controlled -Icatibant Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
Randomized Controlled-Tranexamic Acid Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) 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 were treated in the open label phase with icatibant
Total Total of all reporting groups

Baseline Measures
    Randomized Controlled -Icatibant     Randomized Controlled-Tranexamic Acid     Controlled Open-label / Laryngeal Attack     Untreated Patients at the Baseline     Total  
Number of Participants  
[units: participants]
  36     38     3     8     85  
Age  
[units: years]
Mean ± Standard Deviation
  40.4  ± 13.59     41.9  ± 12.36     35.0  ± 11.36     40.6  ± 13.51     40.9  ± 12.8  
Gender  
[units: participants]
         
Female     24     23     1     7     55  
Male     12     15     2     1     30  
Region of Enrollment  
[units: participants]
         
Austria     3     4     0     1     8  
France     3     1     0     2     6  
Germany     13     12     0     0     25  
Hungary     3     3     0     0     6  
Ireland     0     1     0     0     1  
Israel     4     4     3     4     15  
Italy     3     5     0     1     9  
Lithuania     1     2     0     0     3  
Poland     1     2     0     0     3  
Sweden     3     2     0     0     5  
Switzerland     2     2     0     0     4  



  Outcome Measures
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1.  Primary:   Time to Onset of Symptom Relief.   [ Time Frame: 2 days ]

2.  Secondary:   Time to Almost Complete Symptom Relief   [ Time Frame: 48 hours ]


  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


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00500656     History of Changes
Other Study ID Numbers: JE049 #2102
Study First Received: July 12, 2007
Results First Received: October 30, 2013
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency