Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE) (FAST2)
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| ClinicalTrials.gov Identifier: NCT00500656 |
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Recruitment Status :
Completed
First Posted : July 13, 2007
Results First Posted : June 9, 2014
Last Update Posted : February 16, 2015
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Sponsor:
Shire
Information provided by (Responsible Party):
Shire
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Hereditary Angioedema |
| Interventions |
Drug: Icatibant Drug: Tranexamic Acid Drug: Oral Placebo Drug: S.C. Placebo |
| Enrollment | 85 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | 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 |
| Arm/Group Title | Randomized Controlled -Icatibant | Randomized Controlled-Tranexamic Acid | Controlled Open-label / Laryngeal Attack | Untreated Patients at the Baseline |
|---|---|---|---|---|
 Arm/Group Description |
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. | 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. | Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase. | 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 |
| Period Title: Controlled Phase | ||||
| Started | 36 | 38 | 3 | 8 |
| Completed | 26 | 28 | 2 | 0 |
| Not Completed | 10 | 10 | 1 | 8 |
| Period Title: Open Label Extension (OLE) Phase | ||||
| Started | 23 [1] | 21 [2] | 2 | 8 [3] |
| Completed | 16 | 9 | 1 | 6 |
| Not Completed | 7 | 12 | 1 | 2 |
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[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
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Baseline Characteristics
| Arm/Group Title | Randomized Controlled -Icatibant | Randomized Controlled-Tranexamic Acid | Controlled Open-label / Laryngeal Attack | Untreated Patients at the Baseline | Total | |
|---|---|---|---|---|---|---|
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Arm/Group Description |
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. | 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. | Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase. | 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 of all reporting groups | |
| Overall Number of Baseline Participants | 36 | 38 | 3 | 8 | 85 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 36 participants | 38 participants | 3 participants | 8 participants | 85 participants | |
| 40.4 (13.59) | 41.9 (12.36) | 35.0 (11.36) | 40.6 (13.51) | 40.9 (12.8) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 36 participants | 38 participants | 3 participants | 8 participants | 85 participants | |
| Female |
24 66.7%
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23 60.5%
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1 33.3%
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7 87.5%
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55 64.7%
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| Male |
12 33.3%
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15 39.5%
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2 66.7%
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1 12.5%
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30 35.3%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 36 participants | 38 participants | 3 participants | 8 participants | 85 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
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Alan Kimura, MD, PhD |
| Organization: | Shire Human Genetic Therapies, Inc. |
| Phone: | 781-482-0738 |
| EMail: | akimura@shire.com |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Shire |
| ClinicalTrials.gov Identifier: | NCT00500656 |
| Other Study ID Numbers: |
JE049 #2102 2004-001540-71 ( EudraCT Number ) |
| First Submitted: | July 12, 2007 |
| First Posted: | July 13, 2007 |
| Results First Submitted: | October 30, 2013 |
| Results First Posted: | June 9, 2014 |
| Last Update Posted: | February 16, 2015 |