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A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00912093
First Posted: June 3, 2009
Last Update Posted: September 22, 2014
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.
Information provided by (Responsible Party):
Shire
Results First Submitted: July 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hereditary 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
No text entered.

Reporting Groups
  Description
Randomized-Icatibant (Blinded Treatment)-Non-laryngeal Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase
Randomized-Placebo (Blinded Treatment)-Non-laryngeal Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
Randomized-Icatibant (Blinded Treatment)-Laryngeal Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase
Randomized-Placebo (Blinded Treatment)-Laryngeal Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
Open-Label Icatibant-Severe Laryngeal Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant, 30 mg in the controlled phase

Participant Flow for 2 periods

Period 1:   The Controlled Phase
    Randomized-Icatibant (Blinded Treatment)-Non-laryngeal   Randomized-Placebo (Blinded Treatment)-Non-laryngeal   Randomized-Icatibant (Blinded Treatment)-Laryngeal   Randomized-Placebo (Blinded Treatment)-Laryngeal   Open-Label Icatibant-Severe Laryngeal
STARTED   43   45   3   2   5 
COMPLETED   43   43   3   2   4 
NOT COMPLETED   0   2   0   0   1 
Death                0                1                0                0                0 
Medical Condition                0                1                0                0                0 
Lost to Follow-up                0                0                0                0                1 

Period 2:   The Open Label Extension (OLE) Phase
    Randomized-Icatibant (Blinded Treatment)-Non-laryngeal   Randomized-Placebo (Blinded Treatment)-Non-laryngeal   Randomized-Icatibant (Blinded Treatment)-Laryngeal   Randomized-Placebo (Blinded Treatment)-Laryngeal   Open-Label Icatibant-Severe Laryngeal
STARTED   38   35   3   2   4 
COMPLETED   38   35   3   2   4 
NOT COMPLETED   0   0   0   0   0 



  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 (Blinded Treatment)--Non-laryngeal Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
Randomized-Placebo (Blinded Treatment)-Non-laryngeal Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
Randomized-Icatibant (Blinded Treatment)--Laryngeal Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
Randomized-Placebo (Blinded Treatment)-Laryngeal Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
Open-Label Icatibant-Severe Laryngeal Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant 30 mg in the controlled phase
Total Total of all reporting groups

Baseline Measures
   Randomized-Icatibant (Blinded Treatment)--Non-laryngeal   Randomized-Placebo (Blinded Treatment)-Non-laryngeal   Randomized-Icatibant (Blinded Treatment)--Laryngeal   Randomized-Placebo (Blinded Treatment)-Laryngeal   Open-Label Icatibant-Severe Laryngeal   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   45   3   2   5   98 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.1  (13.69)   36.6  (11.18)   40.3  (6.66)   50.0  (22.63)   41.6  (11.78)   37.0  (12.46) 
Gender 
[Units: Participants]
           
Female   27   29   2   1   2   61 
Male   16   16   1   1   3   37 
Race/Ethnicity, Customized 
[Units: Participants]
           
American Indian or Alaska Native   0   0   0   0   0   0 
Asian   0   0   0   0   0   0 
Black or African American   3   0   0   0   0   3 
Native Hawaiian or Other Pacific   0   0   0   0   0   0 
White   38   40   3   2   4   87 
Other   2   5   0   0   1   8 
Region of Enrollment 
[Units: Participants]
           
United States   26   32   2   2   3   65 
Hungary   3   1   0   0   0   4 
Canada   1   0   0   0   0   1 
Ukraine   0   1   0   0   0   1 
Romania   3   1   1   0   0   5 
Australia   2   3   0   0   0   5 
Russian Federation   2   1   0   0   0   3 
South Africa   2   1   0   0   1   4 
Israel   4   5   0   0   1   10 
Weight (kg) 
[Units: Participants]
           
<= 50 kg   4   2   0   0   0   6 
>50-75 kg   16   20   1   2   0   39 
>75-100 kg   14   13   1   0   3   31 
>100 kg   9   10   1   0   2   22 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient   [ Time Frame: Up to 120 hours post-dose ]

2.  Secondary:   Time to Onset of Primary Symptom Relief   [ Time Frame: Up to 120 hours post-dose ]

3.  Secondary:   Time to Almost Complete Symptom Relief   [ Time Frame: Up to 120 Hours post treatment ]

4.  Secondary:   Time to Subject-Assessed Initial Symptom Improvement   [ Time Frame: Up to 120 hours post-dose ]

5.  Secondary:   Time to Investigator-Assessed Initial Symptom Improvement   [ Time Frame: Up to 120 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Alan Kimura, MD, PhD
Organization: Shire
phone: 1-617-482-0738
e-mail: akimura@shire.com


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

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00912093     History of Changes
Other Study ID Numbers: HGT-FIR-054
2009-015606-19 ( EudraCT Number )
First Submitted: June 2, 2009
First Posted: June 3, 2009
Results First Submitted: July 11, 2014
Results First Posted: August 6, 2014
Last Update Posted: September 22, 2014