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

NCT00912093 | Completed Phase 3 Results

• 2 other identifiers: HGT-FIR-0542009-015606-19
• Study Type: interventional
• Target: 98
• Locations: 9 countries
• Sites: 64

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).

Conditions

Hereditary Angioedema

Keywords

HAE; Type I HAE; Type II HAE

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 120 hours post-dose

Secondary Outcomes (4)

• Time to Onset of Primary Symptom Relief

  Up to 120 hours post-dose

• Time to Almost Complete Symptom Relief

  Up to 120 Hours post treatment

• Time to Subject-Assessed Initial Symptom Improvement

  Up to 120 hours post-dose

• Time to Investigator-Assessed Initial Symptom Improvement

  Up to 120 hours post-dose

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Single subcutaneous injection of matching placebo

Drug: Placebo

Icatibant

EXPERIMENTAL

Single subcutaneous injection of icatibant, 30 mg

Drug: Icatibant

Interventions

Icatibant DRUG

Single subcutaneous injection of icatibant, 30 mg

Also known as: Firazyr

Icatibant

Placebo DRUG

Single subcutaneous injection of matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (64)

Primary Care Associates of Alabaster

Alabaster, Alabama, 35007, United States

Location

UAB Lung Health Center

Birmingham, Alabama, 35294, United States

Location

Medical Research of AZ A Division of Allergy & Immunology Assoc

Scottsdale, Arizona, 85251, United States

Location

Little Rock Allergy & Asthma Clinic, PA

Little Rock, Arkansas, 72205, United States

Location

Allergy and Asthma Insititute of the Valley

Granada Hills, California, 91344, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

UCLA - Clinical Immunology & Allergy

Los Angeles, California, 90095, United States

Location

Speciality Medical Clinic & Research Center

Stanford, California, 27330, United States

Location

Standford University

Stanford, California, 94305, United States

Location

Asthma & Allergy Associates, PC

Colorado Springs, Colorado, 80907, United States

Location

Medical Associates of Brevard

Melbourne, Florida, 32935, United States

Location

University of South Florida Division of Allergy and Immunology

Tampa, Florida, 33613, United States

Location

Family Allergy and Asthma Center, PC

Atlanta, Georgia, 30342, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Research Institute of Deaconess Clinic

Evansville, Indiana, 47713, United States

Location

University of Iowa Asthma Center/ Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

LSUHSC Allergy & Immunology

Shreveport, Louisiana, 71130, United States

Location

Institute for Asthman & Allergy, P.C.

Chevy Chase, Maryland, 20815-6901, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

The Asthma Center

St Louis, Missouri, 63141, United States

Location

University of Reno Nevada School of Medicine

Reno, Nevada, 89503, United States

Location

STARx Research Center, LLC

Edison, New Jersey, 08820, United States

Location

Winthrop University Hospital Clinical Trials Center

Mineola, New York, 11501, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Montefiore Medical Center/Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Allergy Partners of Western North Carolina

Asheville, North Carolina, 28801, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Division of Immunology/Allergy

Cincinnati, Ohio, 45267, United States

Location

Optimed Research, LTD

Columbus, Ohio, 43235, United States

Location

Tulsa Allergy Clinic

Tulsa, Oklahoma, 74133, United States

Location

Baker Allergy, Asthma & Dermatology Research Center LLC

Lake Oswego, Oregon, 97035, United States

Location

Valley Clinical Research Center

Bethlehem, Pennsylvania, 18020, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Pittsburgh (of UMPC)

Pittsburgh, Pennsylvania, 15224, United States

Location

AARA Research Center

Dallas, Texas, 75231, United States

Location

University of Texas Medical Branch (UTMB)

Galveston, Texas, 77555-0561, United States

Location

Texas A&M Health Science Center College of Medicine

Houston, Texas, 77030, United States

Location

Allergy and Asthma Research Center, P.A.

San Antonio, Texas, 78229, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Canberra Hospital Department of Immunology

Garran, Australian Capital Territory, Australia

Location

Dept of Medicine Immunology & Allergy Campbelltown Hospital

Campbelltown, New South Wales, 2560, Australia

Location

Royal Melbourne Hospital Department of Immunology

Parkville, Victoria, 3050, Australia

Location

Royal Adelaide Hospital

Adelaide, Australia

Location

NACTRC

Edmonton, Alberta, T6G 2H7, Canada

Location

Allergy & Asthma Research Centre

Ottawa, Ontario, K1Y 4G2, Canada

Location

Centre de recherché Appliquée en allergie de Québec

Québec, Quebec, G1V 5M6, Canada

Location

3rd Department of Internal Medicine Semmelweis University

Budapest, 1125, Hungary

Location

Bnai-Zion Medical Center Division of Immunology & Allergy

Haifa, 31048, Israel

Location

Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

The Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Spitalul Clinic Judetean Mures Sectia Medicina Interna

Târgu Mureş, Transylvania, 540103, Romania

Location

Medical Academy of Postgraduate Education

Saint Petersburg, Sankt-Peterburg, 194291, Russia

Location

Autonomous Non Commercial Organization

Saint Petersburg, Sankt-Peterburg, 198216, Russia

Location

State Healthcare Institution of City of Moscow

Moscow, 115446, Russia

Location

State Enterprise State Scientific Centre

Moscow, 115478, Russia

Location

State Educational Institution of Additional Profess. Edu. Moscow

Moscow, 123182, Russia

Location

Municipal Medical & Preventive Treatment Institution

Smolensk, 214001, Russia

Location

Regional Clinical Center of Specialized Medical Treatment

Vladivostok, 690091, Russia

Location

Allergy Diagnostic and Clinical Research Unit (ADCRU)

Cape Town, Mowbray, 7700, South Africa

Location

Ivano-Frankivsk national Medical University

Ivano-Frankivsk, 76018, Ukraine

Location

National Medical Academy for Postgraduate Education

Kyiv, 01133, Ukraine

Location

Institute of Otolaryngology

Kyiv, 03680, Ukraine

Location

Ukranian Medical Stomatological Academy Dept of Int Diseases

Poltava, 36039, Ukraine

Location

Vinnitsa Medical Academy Chair of Internal Disease

Vinnitsa, 21029, Ukraine

Location

Related Publications (4)

• 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.

  PMID: 26556097 DERIVED

• 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.

  PMID: 25198193 DERIVED

• 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.

  PMID: 23167682 DERIVED

• 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.

  PMID: 22123383 DERIVED

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

icatibant

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 3, 2009
• Study Start: July 16, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 11, 2021
• Results First Posted: August 6, 2014

Record last verified: 2021-06

Locations

AU (4); ZA (1); US (39); RU (7); HU (1); CA (3); UA (5); RO (1); IL (3)