Status:
COMPLETED
A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
Lead Sponsor:
Shire
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is being conducted to evaluate the efficacy and safety of icatibant compared to placebo in patients experiencing acute attacks of hereditary angioedema (HAE).
Detailed Description
This Phase III study consisted of two parts: A controlled phase and an open label extension (OLE) phase. The controlled phase describes the double blind part of the study and was intended to evaluate...
Eligibility Criteria
Inclusion
- Each patient must meet the following criteria to be enrolled in this study.
- The patient is ≥18 years old at the time of informed consent.
- The patient has a documented diagnosis of HAE type I or II. The diagnosis will be confirmed either by documented decreased C4 levels and/or immunogenic or functional C1-INH deficiency results (\<50% of normal levels) consistent with HAE types I and II or by medical history.
- The current HAE attack must be in the cutaneous, abdominal and/or laryngeal (inclusive of laryngeal and pharyngeal) areas.
- Cutaneous or abdominal HAE attacks must be moderate to very severe as determined by investigator global assessment at pre-treatment assessments
- The patient must report at least 1 VAS score ≥ 30mm
- The patient commences treatment within 6 hours of the attack becoming at least mild (laryngeal) or moderate (non-laryngeal) in severity, but not more than 12 hours after the onset of the attack.
- Women of childbearing potential must have a negative urine pregnancy test and must use appropriate methods to prevent pregnancy during their participation in the study.
Exclusion
- Patients who meet any of the following criteria will be excluded from the study.
- The patient has a diagnosis of angioedema other than HAE type I or II.
- The patient has received previous treatment with icatibant.
- The patient has participated in a clinical trial and has received treatment with another investigational medicinal product within the past 30 days.
- The patient has received treatment with any pain medication since the onset of the current angioedema attack.
- The patient has received replacement therapy (fresh frozen plasma \[FFP\], C1-INH products) less than 5 days (120 hours) from the onset of the current angioedema attack.
- The patient is receiving treatment with angiotensin converting enzyme (ACE) inhibitors.
- Evidence of coronary artery disease based on medical history or screening examination in particular unstable angina pectoris or severe coronary heart disease;
- The patient has a serious concomitant illness or condition that, in the opinion of the Investigator, would be a contraindication for participation in the trial.
- The patient is pregnant or breastfeeding.
Key Trial Info
Start Date :
July 16 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00912093
Start Date
July 16 2009
End Date
October 1 2010
Last Update
June 11 2021
Active Locations (64)
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1
Primary Care Associates of Alabaster
Alabaster, Alabama, United States, 35007
2
UAB Lung Health Center
Birmingham, Alabama, United States, 35294
3
Medical Research of AZ A Division of Allergy & Immunology Assoc
Scottsdale, Arizona, United States, 85251
4
Little Rock Allergy & Asthma Clinic, PA
Little Rock, Arkansas, United States, 72205