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

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Disease Information

Descriptive Information
Brief Title † A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
Official Title † A Phase III Randomized, Double-Blind,Placebo-Controlled, Multicenter Study of Icatibant for Subcutaneous Injection in Patients With Acute Attacks of Hereditary Angioedema (HAE)
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 the efficacy and safety of icatibant compared with placebo for the first treated cutaneous and/or abdominal attack. Patients with moderate to severe abdominal or cutaneous attacks were randomized to receive a single, blinded, subcutaneous injection of icatibant (30 mg) or placebo. After a protocol amendment, patients with mild to moderate laryngeal HAE attacks were also randomized to receive a single, blinded subcutaneous injection of icatibant (30 mg) or placebo in order to obtain blinded, controlled efficacy and safety data for this subset of subjects. Patients experiencing severe laryngeal attacks (post-amendment) or mild to severe laryngeal attacks (pre-amendment) were to receive open-label icatibant. After treatment of the first attack in the controlled phase, patients were eligible to enter the OLE phase. In the OLE phase, patients who experienced angioedema attacks severe enough to warrant treatment were to be treated with s.c. icatibant as appropriate until the study was discontinued or the product was commercially available.
Study Phase Phase 3
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
Primary Outcome Measure † Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient
Secondary Outcome Measure † Time to Onset of Primary Symptom Relief
Condition † Hereditary Angioedema
Intervention † DrugIcatibant
Study Arms / Comparison Groups Placebo Single subcutaneous injection of matching placebo Icatibant Single subcutaneous injection of icatibant, 30 mg
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 98
Start Date † June 2009
Completion Date July 2012
Primary Completion Date July 2012
Eligibility Criteria † Inclusion Criteria: Each patient must meet the following criteria to be enrolled in this study. 1. The patient is ≥18 years old at the time of informed consent. 2. 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 (
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00912093
Organization ID HGT-FIR-054
Secondary IDs †† 2009-015606-19
Responsible Party Sponsor
Study Sponsor † Shire
Collaborators ††
Investigators † Study Director: Alan Kimura, M.D., PhD, Shire
Information Provided By
Verification Date July 2014
First Received Date † June 2, 2009
Last Updated Date September 11, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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