A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
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ClinicalTrials.gov Identifier: NCT00912093 |
Recruitment Status :
Completed
First Posted : June 3, 2009
Results First Posted : August 6, 2014
Last Update Posted : June 11, 2021
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Sponsor:
Shire
Information provided by (Responsible Party):
Takeda ( Shire )
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Study Type | Interventional |
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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 |
Enrollment | 98 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | 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 |
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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 | 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 | Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase | Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase | 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 |
Period Title: The Controlled Phase | |||||
Started | 43 | 45 | 3 | 2 | 5 |
Completed | 43 | 43 | 3 | 2 | 4 |
Not Completed | 0 | 2 | 0 | 0 | 1 |
Reason Not Completed | |||||
Death | 0 | 1 | 0 | 0 | 0 |
Medical Condition | 0 | 1 | 0 | 0 | 0 |
Lost to Follow-up | 0 | 0 | 0 | 0 | 1 |
Period Title: The Open Label Extension (OLE) Phase | |||||
Started | 38 | 35 | 3 | 2 | 4 |
Completed | 38 | 35 | 3 | 2 | 4 |
Not Completed | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | 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 | |
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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 | 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 | Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase | Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase | 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 of all reporting groups | |
Overall Number of Baseline Participants | 43 | 45 | 3 | 2 | 5 | 98 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
|||||||
Number Analyzed | 43 participants | 45 participants | 3 participants | 2 participants | 5 participants | 98 participants | |
36.1 (13.69) | 36.6 (11.18) | 40.3 (6.66) | 50.0 (22.63) | 41.6 (11.78) | 37.0 (12.46) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 43 participants | 45 participants | 3 participants | 2 participants | 5 participants | 98 participants | |
Female |
27 62.8%
|
29 64.4%
|
2 66.7%
|
1 50.0%
|
2 40.0%
|
61 62.2%
|
|
Male |
16 37.2%
|
16 35.6%
|
1 33.3%
|
1 50.0%
|
3 60.0%
|
37 37.8%
|
|
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 43 participants | 45 participants | 3 participants | 2 participants | 5 participants | 98 participants |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
3 7.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
3 3.1%
|
|
Native Hawaiian or Other Pacific |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
White |
38 88.4%
|
40 88.9%
|
3 100.0%
|
2 100.0%
|
4 80.0%
|
87 88.8%
|
|
Other |
2 4.7%
|
5 11.1%
|
0 0.0%
|
0 0.0%
|
1 20.0%
|
8 8.2%
|
|
Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 43 participants | 45 participants | 3 participants | 2 participants | 5 participants | 98 participants |
United States |
26 60.5%
|
32 71.1%
|
2 66.7%
|
2 100.0%
|
3 60.0%
|
65 66.3%
|
|
Hungary |
3 7.0%
|
1 2.2%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
4 4.1%
|
|
Canada |
1 2.3%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 1.0%
|
|
Ukraine |
0 0.0%
|
1 2.2%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 1.0%
|
|
Romania |
3 7.0%
|
1 2.2%
|
1 33.3%
|
0 0.0%
|
0 0.0%
|
5 5.1%
|
|
Australia |
2 4.7%
|
3 6.7%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
5 5.1%
|
|
Russian Federation |
2 4.7%
|
1 2.2%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
3 3.1%
|
|
South Africa |
2 4.7%
|
1 2.2%
|
0 0.0%
|
0 0.0%
|
1 20.0%
|
4 4.1%
|
|
Israel |
4 9.3%
|
5 11.1%
|
0 0.0%
|
0 0.0%
|
1 20.0%
|
10 10.2%
|
|
Weight (kg)
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 43 participants | 45 participants | 3 participants | 2 participants | 5 participants | 98 participants |
<= 50 kg |
4 9.3%
|
2 4.4%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
6 6.1%
|
|
>50-75 kg |
16 37.2%
|
20 44.4%
|
1 33.3%
|
2 100.0%
|
0 0.0%
|
39 39.8%
|
|
>75-100 kg |
14 32.6%
|
13 28.9%
|
1 33.3%
|
0 0.0%
|
3 60.0%
|
31 31.6%
|
|
>100 kg |
9 20.9%
|
10 22.2%
|
1 33.3%
|
0 0.0%
|
2 40.0%
|
22 22.4%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
Shire's agreements with investigators vary. All agreements provide Shire the right to embargo communications regarding trial results prior to public release for a period ≤180 days from the time submitted to Shire for review. Shire does not prohibit publication, but can require the removal of confidential information (excluding trial results) and can request postponement of a single-center publication until after disclosure of the trial's multi-center publication.
Results Point of Contact
Name/Title: | Study Director |
Organization: | Shire |
Phone: | +1 866 842 5335 |
EMail: | ClinicalTransparency@shire.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Takeda ( Shire ) |
ClinicalTrials.gov Identifier: | NCT00912093 |
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: | June 11, 2021 |