Back to resultsA Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
Primary Purpose
Hereditary Angioedema
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Icatibant
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hereditary Angioedema focused on measuring HAE, Type I HAE, Type II HAE
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Sites / Locations
- Primary Care Associates of Alabaster
- UAB Lung Health Center
- Medical Research of AZ A Division of Allergy & Immunology Assoc
- Little Rock Allergy & Asthma Clinic, PA
- Allergy and Asthma Insititute of the Valley
- University of California San Diego
- UCLA - Clinical Immunology & Allergy
- Speciality Medical Clinic & Research Center
- Standford University
- Asthma & Allergy Associates, PC
- Medical Associates of Brevard
- University of South Florida Division of Allergy and Immunology
- Family Allergy and Asthma Center, PC
- Rush University Medical Center
- Research Institute of Deaconess Clinic
- University of Iowa Asthma Center/ Hospitals & Clinics
- LSUHSC Allergy & Immunology
- Institute for Asthman & Allergy, P.C.
- Massachusetts General Hospital
- The Asthma Center
- University of Reno Nevada School of Medicine
- STARx Research Center, LLC
- Montefiore Medical Center/Albert Einstein College of Medicine
- Winthrop University Hospital Clinical Trials Center
- Mount Sinai School of Medicine
- Allergy Partners of Western North Carolina
- Duke University Medical Center
- University of Cincinnati Division of Immunology/Allergy
- Optimed Research, LTD
- Tulsa Allergy Clinic
- Baker Allergy, Asthma & Dermatology Research Center LLC
- Valley Clinical Research Center
- Penn State Hershey Medical Center
- Children's Hospital of Pittsburgh (of UMPC)
- AARA Research Center
- University of Texas Medical Branch (UTMB)
- Texas A&M Health Science Center College of Medicine
- Allergy and Asthma Research Center, P.A.
- University of Utah
- Canberra Hospital Department of Immunology
- Dept of Medicine Immunology & Allergy Campbelltown Hospital
- Royal Melbourne Hospital Department of Immunology
- Royal Adelaide Hospital
- NACTRC
- Allergy & Asthma Research Centre
- Centre de recherché Appliquée en allergie de Québec
- 3rd Department of Internal Medicine Semmelweis University
- Bnai-Zion Medical Center Division of Immunology & Allergy
- Tel Aviv Medical Center
- The Chaim Sheba Medical Center
- Spitalul Clinic Judetean Mures Sectia Medicina Interna
- Medical Academy of Postgraduate Education
- Autonomous Non Commercial Organization
- State Healthcare Institution of City of Moscow
- State Enterprise State Scientific Centre
- State Educational Institution of Additional Profess. Edu. Moscow
- Municipal Medical & Preventive Treatment Institution
- Regional Clinical Center of Specialized Medical Treatment
- Allergy Diagnostic and Clinical Research Unit (ADCRU)
- Ivano-Frankivsk national Medical University
- National Medical Academy for Postgraduate Education
- Institute of Otolaryngology
- Ukranian Medical Stomatological Academy Dept of Int Diseases
- Vinnitsa Medical Academy Chair of Internal Disease
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Icatibant
Arm Description
Single subcutaneous injection of matching placebo
Single subcutaneous injection of icatibant, 30 mg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00912093
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 16, 2009 (Actual)
Primary Completion Date
October 1, 2010 (Actual)
Study Completion Date
October 1, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Angioedema
Keywords
HAE, Type I HAE, Type II HAE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single subcutaneous injection of matching placebo
Arm Title
Icatibant
Arm Type
Experimental
Arm Description
Single subcutaneous injection of icatibant, 30 mg
Intervention Type
Drug
Intervention Name(s)
Icatibant
Other Intervention Name(s)
Firazyr
Intervention Description
Single subcutaneous injection of icatibant, 30 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single subcutaneous injection of matching placebo
Primary Outcome Measure Information:
Title
Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient
Description
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.
Time Frame
Up to 120 hours post-dose
Secondary Outcome Measure Information:
Title
Time to Onset of Primary Symptom Relief
Description
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.
Time Frame
Up to 120 hours post-dose
Title
Time to Almost Complete Symptom Relief
Description
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.
Time Frame
Up to 120 Hours post treatment
Title
Time to Subject-Assessed Initial Symptom Improvement
Description
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.
Time Frame
Up to 120 hours post-dose
Title
Time to Investigator-Assessed Initial Symptom Improvement
Description
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.
Time Frame
Up to 120 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Primary Care Associates of Alabaster
City
Alabaster
State/Province
Alabama
ZIP/Postal Code
35007
Country
United States
Facility Name
UAB Lung Health Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Medical Research of AZ A Division of Allergy & Immunology Assoc
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Little Rock Allergy & Asthma Clinic, PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Allergy and Asthma Insititute of the Valley
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCLA - Clinical Immunology & Allergy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Speciality Medical Clinic & Research Center
City
Stanford
State/Province
California
ZIP/Postal Code
27330
Country
United States
Facility Name
Standford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Asthma & Allergy Associates, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Medical Associates of Brevard
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
University of South Florida Division of Allergy and Immunology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Family Allergy and Asthma Center, PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Research Institute of Deaconess Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
University of Iowa Asthma Center/ Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
LSUHSC Allergy & Immunology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Institute for Asthman & Allergy, P.C.
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815-6901
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
The Asthma Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
University of Reno Nevada School of Medicine
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Facility Name
STARx Research Center, LLC
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
Montefiore Medical Center/Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Winthrop University Hospital Clinical Trials Center
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Allergy Partners of Western North Carolina
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati Division of Immunology/Allergy
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Optimed Research, LTD
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Tulsa Allergy Clinic
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Baker Allergy, Asthma & Dermatology Research Center LLC
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Valley Clinical Research Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18020
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Children's Hospital of Pittsburgh (of UMPC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
AARA Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Texas Medical Branch (UTMB)
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0561
Country
United States
Facility Name
Texas A&M Health Science Center College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Allergy and Asthma Research Center, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Canberra Hospital Department of Immunology
City
Garran
State/Province
Australian Capital Territory
Country
Australia
Facility Name
Dept of Medicine Immunology & Allergy Campbelltown Hospital
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2560
Country
Australia
Facility Name
Royal Melbourne Hospital Department of Immunology
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Facility Name
NACTRC
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2H7
Country
Canada
Facility Name
Allergy & Asthma Research Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4G2
Country
Canada
Facility Name
Centre de recherché Appliquée en allergie de Québec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 5M6
Country
Canada
Facility Name
3rd Department of Internal Medicine Semmelweis University
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Bnai-Zion Medical Center Division of Immunology & Allergy
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Spitalul Clinic Judetean Mures Sectia Medicina Interna
City
Targu Mures
State/Province
Transylvania
ZIP/Postal Code
540103
Country
Romania
Facility Name
Medical Academy of Postgraduate Education
City
St Petersburg
State/Province
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Autonomous Non Commercial Organization
City
St Petersburg
State/Province
Saint Petersburg
ZIP/Postal Code
198216
Country
Russian Federation
Facility Name
State Healthcare Institution of City of Moscow
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Facility Name
State Enterprise State Scientific Centre
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
State Educational Institution of Additional Profess. Edu. Moscow
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Municipal Medical & Preventive Treatment Institution
City
Smolensk
ZIP/Postal Code
214001
Country
Russian Federation
Facility Name
Regional Clinical Center of Specialized Medical Treatment
City
Vladivostok
ZIP/Postal Code
690091
Country
Russian Federation
Facility Name
Allergy Diagnostic and Clinical Research Unit (ADCRU)
City
Cape Town
State/Province
Mowbray
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Ivano-Frankivsk national Medical University
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
National Medical Academy for Postgraduate Education
City
Kyiv
ZIP/Postal Code
01133
Country
Ukraine
Facility Name
Institute of Otolaryngology
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Ukranian Medical Stomatological Academy Dept of Int Diseases
City
Poltava
ZIP/Postal Code
36039
Country
Ukraine
Facility Name
Vinnitsa Medical Academy Chair of Internal Disease
City
Vinnitsa
ZIP/Postal Code
21029
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
26556097
Citation
Lumry WR, Farkas H, Moldovan D, Toubi E, Baptista J, Craig T, Riedl M. Icatibant for Multiple Hereditary Angioedema Attacks across the Controlled and Open-Label Extension Phases of FAST-3. Int Arch Allergy Immunol. 2015;168(1):44-55. doi: 10.1159/000441060. Epub 2015 Nov 11.
Results Reference
derived
PubMed Identifier
25198193
Citation
Maurer M, Longhurst HJ, Fabien V, Li HH, Lumry WR. Treatment of hereditary angioedema with icatibant: efficacy in clinical trials versus effectiveness in the real-world setting. Allergy Asthma Proc. 2014 Sep-Oct;35(5):377-81. doi: 10.2500/aap.2014.35.3780. Epub 2014 Aug 6.
Results Reference
derived
PubMed Identifier
23167682
Citation
Bas M. Clinical efficacy of icatibant in the treatment of acute hereditary angioedema during the FAST-3 trial. Expert Rev Clin Immunol. 2012 Nov;8(8):707-17. doi: 10.1586/eci.12.67.
Results Reference
derived
PubMed Identifier
22123383
Citation
Lumry WR, Li HH, Levy RJ, Potter PC, Farkas H, Moldovan D, Riedl M, Li H, Craig T, Bloom BJ, Reshef A. Randomized placebo-controlled trial of the bradykinin B(2) receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial. Ann Allergy Asthma Immunol. 2011 Dec;107(6):529-37. doi: 10.1016/j.anai.2011.08.015. Epub 2011 Oct 5.
Results Reference
derived
Learn more about this trial
A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
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