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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Tracking Information | ||||
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First Submitted Date ICMJE | June 2, 2009 | |||
First Posted Date ICMJE | June 3, 2009 | |||
Results First Submitted Date ICMJE | July 11, 2014 | |||
Results First Posted Date ICMJE | August 6, 2014 | |||
Last Update Posted Date | June 11, 2021 | |||
Actual Study Start Date ICMJE | July 16, 2009 | |||
Actual Primary Completion Date | October 1, 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient [ Time Frame: Up to 120 hours post-dose ] Time to onset of symptom relief was calculated from study drug administration to onset of symptom relief, where onset of symptom relief was defined as the earliest of 3 consecutive measurements in which there was a 50% reduction from pretreatment in composite VAS score. Composite VAS score comprised 3 symptoms, including skin swelling, skin pain, and abdominal pain, for cutaneous and abdominal attacks and 5 symptoms, including skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change, for laryngeal attacks. Subjects who did not achieve symptom relief within the observation period were censored at the last observation time.
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Original Primary Outcome Measures ICMJE |
Time to symptom relief for an acute attack, as assessed by the patient [ Time Frame: Patients monitored for 8 hrs or until stable ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3) | |||
Official Title ICMJE | 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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Hereditary Angioedema | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
98 | |||
Original Estimated Enrollment ICMJE |
88 | |||
Actual Study Completion Date ICMJE | October 1, 2010 | |||
Actual Primary Completion Date | October 1, 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Each patient must meet the following criteria to be enrolled in this study.
Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Canada, Hungary, Israel, Romania, Russian Federation, South Africa, Ukraine, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00912093 | |||
Other Study ID Numbers ICMJE | HGT-FIR-054 2009-015606-19 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Takeda ( Shire ) | |||
Original Responsible Party | Kimberly Rosen, MD, Medical Director, Shire HGT, Inc. | |||
Current Study Sponsor ICMJE | Shire | |||
Original Study Sponsor ICMJE | Jerini AG | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Takeda | |||
Verification Date | June 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |