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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hereditary Angioedema

In brief

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).

Key facts

Study ID

NCT00912093

Run by

Shire

People needed

98

Starts

2009-07-16

Expected to finish

2010-10-01

Last updated by the study team

2021-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UAB Lung Health Center — Birmingham, Alabama, United States
• Medical Research of AZ A Division of Allergy & Immunology Assoc — Scottsdale, Arizona, United States
• Little Rock Allergy & Asthma Clinic, PA — Little Rock, Arkansas, United States
• Allergy and Asthma Insititute of the Valley — Granada Hills, California, United States
• University of California San Diego — La Jolla, California, United States
• UCLA - Clinical Immunology & Allergy — Los Angeles, California, United States
• Speciality Medical Clinic & Research Center — Stanford, California, United States
• Standford University — Stanford, California, United States
• Asthma & Allergy Associates, PC — Colorado Springs, Colorado, United States
• Medical Associates of Brevard — Melbourne, Florida, United States
• University of South Florida Division of Allergy and Immunology — Tampa, Florida, United States
• Family Allergy and Asthma Center, PC — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Research Institute of Deaconess Clinic — Evansville, Indiana, United States
• University of Iowa Asthma Center/ Hospitals & Clinics — Iowa City, Iowa, United States
• LSUHSC Allergy & Immunology — Shreveport, Louisiana, United States
• Institute for Asthman & Allergy, P.C. — Chevy Chase, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• The Asthma Center — St Louis, Missouri, United States
• University of Reno Nevada School of Medicine — Reno, Nevada, United States
• STARx Research Center, LLC — Edison, New Jersey, United States
• Winthrop University Hospital Clinical Trials Center — Mineola, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Montefiore Medical Center/Albert Einstein College of Medicine — The Bronx, New York, United States
• Primary Care Associates of Alabaster — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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