Please note that the ANZCTR website will be unavailable from 1pm until 2pm (AEST) on Wednesday 29th May for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00912093




Registration number
NCT00912093
Ethics application status
Date submitted
2/06/2009
Date registered
2/06/2009
Date last updated
11/09/2014

Titles & IDs
Public title
A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
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)
Secondary ID [1] 0 0
2009-015606-19
Secondary ID [2] 0 0
HGT-FIR-054
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hereditary Angioedema 0 0
Hereditary Angioedema 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Icatibant
Treatment: Drugs - Placebo
Treatment: Drugs - Icatibant
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - Single subcutaneous injection of matching placebo

Experimental: Icatibant - Single subcutaneous injection of icatibant, 30 mg

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

Treatment: Drugs: Icatibant
Single subcutaneous injection of icatibant, 30 mg

Treatment: Drugs: Placebo
Single subcutaneous injection of matching placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient - 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.
Timepoint [1] 0 0
Up to 120 hours post-dose
Primary outcome [2] 0 0
Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient - 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.
Timepoint [2] 0 0
Up to 120 hours post-dose
Secondary outcome [1] 0 0
Time to Onset of Primary Symptom Relief - 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.
Timepoint [1] 0 0
Up to 120 hours post-dose
Secondary outcome [2] 0 0
Time to Almost Complete Symptom Relief - 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.
Timepoint [2] 0 0
Up to 120 Hours post treatment
Secondary outcome [3] 0 0
Time to Subject-Assessed Initial Symptom Improvement - 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.
Timepoint [3] 0 0
Up to 120 hours post-dose
Secondary outcome [4] 0 0
Time to Investigator-Assessed Initial Symptom Improvement - 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.
Timepoint [4] 0 0
Up to 120 hours post-dose
Secondary outcome [5] 0 0
Time to Onset of Primary Symptom Relief - 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.
Timepoint [5] 0 0
Up to 120 hours post-dose
Secondary outcome [6] 0 0
Time to Almost Complete Symptom Relief - 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.
Timepoint [6] 0 0
Up to 120 Hours post treatment
Secondary outcome [7] 0 0
Time to Subject-Assessed Initial Symptom Improvement - 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.
Timepoint [7] 0 0
Up to 120 hours post-dose
Secondary outcome [8] 0 0
Time to Investigator-Assessed Initial Symptom Improvement - 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.
Timepoint [8] 0 0
Up to 120 hours post-dose

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
Canberra Hospital Department of Immunology - Woden
Recruitment hospital [2] 0 0
Dept of Medicine Immunology & Allergy Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 0 0
Royal Melbourne Hospital Department of Immunology - Parkville
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Woden
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Israel
State/province [29] 0 0
Haifa
Country [30] 0 0
Israel
State/province [30] 0 0
Tel Aviv
Country [31] 0 0
Israel
State/province [31] 0 0
Tel Hashomer
Country [32] 0 0
Romania
State/province [32] 0 0
Tigru-Mures
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Moscow
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Smolensk
Country [35] 0 0
Russian Federation
State/province [35] 0 0
St Petersburg
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Vladivostok
Country [37] 0 0
South Africa
State/province [37] 0 0
Mowbray
Country [38] 0 0
Ukraine
State/province [38] 0 0
Ivano-Frankivsk
Country [39] 0 0
Ukraine
State/province [39] 0 0
Kyiv
Country [40] 0 0
Ukraine
State/province [40] 0 0
Poltava
Country [41] 0 0
Ukraine
State/province [41] 0 0
Vinnitsa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shire
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT00912093
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alan Kimura, M.D., PhD
Address 0 0
Shire
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications