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

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Shire Human Genetic Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT00912093
First received: June 2, 2009
Last updated: July 11, 2014
Last verified: July 2014
Results First Received: July 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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
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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.
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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  
Number of Participants  
[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
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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


No publications provided by Shire Human Genetic Therapies, Inc.

Publications automatically indexed to this study:

Responsible Party: Shire Human Genetic Therapies, Inc.
ClinicalTrials.gov Identifier: NCT00912093     History of Changes
Other Study ID Numbers: HGT-FIR-054, 2009-015606-19
Study First Received: June 2, 2009
Results First Received: July 11, 2014
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Ukraine: State Pharmacological Center - Ministry of Health