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

NCT ID: NCT00912093

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-16
• Study Completion Date: 2010-10-01

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.

Conditions

Hereditary Angioedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Single subcutaneous injection of matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single subcutaneous injection of matching placebo

Icatibant

Single subcutaneous injection of icatibant, 30 mg

Group Type: EXPERIMENTAL

Icatibant

Intervention Type: DRUG

Single subcutaneous injection of icatibant, 30 mg

Interventions

Icatibant

Single subcutaneous injection of icatibant, 30 mg

Intervention Type: DRUG

Placebo

Single subcutaneous injection of matching placebo

Intervention Type: DRUG

Other Intervention Names

Firazyr

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Primary Care Associates of Alabaster

Alabaster, Alabama, United States

UAB Lung Health Center

Birmingham, Alabama, United States

Medical Research of AZ A Division of Allergy & Immunology Assoc

Scottsdale, Arizona, United States

Little Rock Allergy & Asthma Clinic, PA

Little Rock, Arkansas, United States

Allergy and Asthma Insititute of the Valley

Granada Hills, California, United States

University of California San Diego

La Jolla, California, United States

UCLA - Clinical Immunology & Allergy

Los Angeles, California, United States

Speciality Medical Clinic & Research Center

Stanford, California, United States

Standford University

Stanford, California, United States

Asthma & Allergy Associates, PC

Colorado Springs, Colorado, United States

Medical Associates of Brevard

Melbourne, Florida, United States

University of South Florida Division of Allergy and Immunology

Tampa, Florida, United States

Family Allergy and Asthma Center, PC

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Research Institute of Deaconess Clinic

Evansville, Indiana, United States

University of Iowa Asthma Center/ Hospitals & Clinics

Iowa City, Iowa, United States

LSUHSC Allergy & Immunology

Shreveport, Louisiana, United States

Institute for Asthman & Allergy, P.C.

Chevy Chase, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

The Asthma Center

St Louis, Missouri, United States

University of Reno Nevada School of Medicine

Reno, Nevada, United States

STARx Research Center, LLC

Edison, New Jersey, United States

Winthrop University Hospital Clinical Trials Center

Mineola, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

Montefiore Medical Center/Albert Einstein College of Medicine

The Bronx, New York, United States

Allergy Partners of Western North Carolina

Asheville, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Cincinnati Division of Immunology/Allergy

Cincinnati, Ohio, United States

Optimed Research, LTD

Columbus, Ohio, United States

Tulsa Allergy Clinic

Tulsa, Oklahoma, United States

Baker Allergy, Asthma & Dermatology Research Center LLC

Lake Oswego, Oregon, United States

Valley Clinical Research Center

Bethlehem, Pennsylvania, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Children's Hospital of Pittsburgh (of UMPC)

Pittsburgh, Pennsylvania, United States

AARA Research Center

Dallas, Texas, United States

University of Texas Medical Branch (UTMB)

Galveston, Texas, United States

Texas A&M Health Science Center College of Medicine

Houston, Texas, United States

Allergy and Asthma Research Center, P.A.

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Canberra Hospital Department of Immunology

Garran, Australian Capital Territory, Australia

Dept of Medicine Immunology & Allergy Campbelltown Hospital

Campbelltown, New South Wales, Australia

Royal Melbourne Hospital Department of Immunology

Parkville, Victoria, Australia

Royal Adelaide Hospital

Adelaide, , Australia

NACTRC

Edmonton, Alberta, Canada

Allergy & Asthma Research Centre

Ottawa, Ontario, Canada

Centre de recherché Appliquée en allergie de Québec

Québec, Quebec, Canada

3rd Department of Internal Medicine Semmelweis University

Budapest, , Hungary

Bnai-Zion Medical Center Division of Immunology & Allergy

Haifa, , Israel

Tel Aviv Medical Center

Tel Aviv, , Israel

The Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Spitalul Clinic Judetean Mures Sectia Medicina Interna

Târgu Mureş, Transylvania, Romania

Medical Academy of Postgraduate Education

Saint Petersburg, Sankt-Peterburg, Russia

Autonomous Non Commercial Organization

Saint Petersburg, Sankt-Peterburg, Russia

State Healthcare Institution of City of Moscow

Moscow, , Russia

State Enterprise State Scientific Centre

Moscow, , Russia

State Educational Institution of Additional Profess. Edu. Moscow

Moscow, , Russia

Municipal Medical & Preventive Treatment Institution

Smolensk, , Russia

Regional Clinical Center of Specialized Medical Treatment

Vladivostok, , Russia

Allergy Diagnostic and Clinical Research Unit (ADCRU)

Cape Town, Mowbray, South Africa

Ivano-Frankivsk national Medical University

Ivano-Frankivsk, , Ukraine

National Medical Academy for Postgraduate Education

Kyiv, , Ukraine

Institute of Otolaryngology

Kyiv, , Ukraine

Ukranian Medical Stomatological Academy Dept of Int Diseases

Poltava, , Ukraine

Vinnitsa Medical Academy Chair of Internal Disease

Vinnitsa, , Ukraine

Countries

United States; Australia; Canada; Hungary; Israel; Romania; Russia; South Africa; Ukraine

References

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.

Reference Type: DERIVED

PMID: 26556097 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25198193 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23167682 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22123383 (View on PubMed)

Other Identifiers

2009-015606-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HGT-FIR-054

Identifier Type: -

Identifier Source: org_study_id