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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00912093
Registration number
NCT00912093
Ethics application status
Date submitted
2/06/2009
Date registered
3/06/2009
Date last updated
11/06/2021
Titles & IDs
Public title
A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
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Scientific 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)
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Secondary ID [1]
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2009-015606-19
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Secondary ID [2]
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HGT-FIR-054
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hereditary Angioedema
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Blood
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Icatibant
Treatment: Drugs - Placebo
Placebo Comparator: Placebo - Single subcutaneous injection of matching placebo
Experimental: Icatibant - Single subcutaneous injection of icatibant, 30 mg
Treatment: Drugs: Icatibant
Single subcutaneous injection of icatibant, 30 mg
Treatment: Drugs: Placebo
Single subcutaneous injection of matching placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient
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Assessment method [1]
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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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Timepoint [1]
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Up to 120 hours post-dose
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Secondary outcome [1]
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Time to Onset of Primary Symptom Relief
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Assessment method [1]
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Time to primary symptom relief was calculated from the time of study drug administration to the onset of primary symptom relief, where onset of primary symptom relief was determined using the subject-assessed VAS score for a single primary symptom (determined by edema location) and defined as the earliest of 3 consecutive non-missing measurements in which a pre-specified reduction from the pretreatment value was met. Subjects who did not achieve primary symptom relief within the observation period were censored at the last observation time.
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Timepoint [1]
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Up to 120 hours post-dose
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Secondary outcome [2]
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Time to Almost Complete Symptom Relief
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Assessment method [2]
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Time to almost complete symptom relief was calculated from the time of study drug administration to almost complete symptom relief, where almost complete symptom relief was defined as the earliest of 3 consecutive non-missing measurements in which all VAS scores <10 mm. Subjects who did not achieve almost complete symptom relief within the observation period were censored at the last observation time.
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Timepoint [2]
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Up to 120 Hours post treatment
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Secondary outcome [3]
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Time to Subject-Assessed Initial Symptom Improvement
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Assessment method [3]
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Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the subject as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time.
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Timepoint [3]
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Up to 120 hours post-dose
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Secondary outcome [4]
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Time to Investigator-Assessed Initial Symptom Improvement
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Assessment method [4]
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Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the investigator as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time.
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Timepoint [4]
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Up to 120 hours post-dose
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Eligibility
Key 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 (<50% of normal levels) consistent with HAE types I and II
or by medical history.
3. The current HAE attack must be in the cutaneous, abdominal and/or laryngeal (inclusive
of laryngeal and pharyngeal) areas.
4. Cutaneous or abdominal HAE attacks must be moderate to very severe as determined by
investigator global assessment at pre-treatment assessments
5. The patient must report at least 1 VAS score = 30mm
6. 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.
7. 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients who meet any of the following criteria will be excluded from the study.
1. The patient has a diagnosis of angioedema other than HAE type I or II.
2. The patient has received previous treatment with icatibant.
3. The patient has participated in a clinical trial and has received treatment with
another investigational medicinal product within the past 30 days.
4. The patient has received treatment with any pain medication since the onset of the
current angioedema attack.
5. 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.
6. The patient is receiving treatment with angiotensin converting enzyme (ACE)
inhibitors.
7. Evidence of coronary artery disease based on medical history or screening examination
in particular unstable angina pectoris or severe coronary heart disease;
8. 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.
9. The patient is pregnant or breastfeeding.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/07/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2010
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Sample size
Target
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Accrual to date
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Final
98
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
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Recruitment hospital [1]
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Canberra Hospital Department of Immunology - Garran
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Recruitment hospital [2]
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Dept of Medicine Immunology & Allergy Campbelltown Hospital - Campbelltown
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Recruitment hospital [3]
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Royal Melbourne Hospital Department of Immunology - Parkville
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Recruitment hospital [4]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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- Garran
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Recruitment postcode(s) [2]
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2560 - Campbelltown
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Recruitment postcode(s) [3]
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3050 - Parkville
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Recruitment postcode(s) [4]
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- Adelaide
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Florida
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Georgia
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Romania
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Transylvania
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Saint Petersburg
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Vinnitsa
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Shire
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00912093
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Study Director
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Address
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Takeda
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00912093
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