EASSI - Evaluation of the Safety of Self-Administration With Icatibant

NCT00997204 | Completed Phase 3 Results

• 2 other identifiers: JE049-31012008-000071-25
• Study Type: interventional
• Target: 151
• Locations: 10 countries
• Sites: 26

Brief Summary

This study is being conducted to explore the clinical safety, local tolerability, convenience and effectiveness of self-treatment of hereditary angioedema (HAE) attacks with subcutaneous injections of icatibant.

Conditions

Hereditary Angioedema

Keywords

HAE; Type I HAE; Type II HAE

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant

  Clinical safety of self-treatment of acute HAE attacks with s.c. injections of icatibant was assessed by calculating the number of AEs occurred during the study. Only those adverse events occurring up to the earlier of 7 days from the start of the naive phase, study discontinuation and start of the self-administration phase are assessed. The Local Tolerability Assessment tool was used. Subjects and Investigators graded erythema/reddening, swelling, burning, pruritus/itching, warm sensation, and skin pain on a 0 to 3 severity scale.

  7 days from the beginning of each phase

Secondary Outcomes (1)

• Clinical Efficacy of Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant, Time to Symptom Relief Using VAS Score for a Single Primary Symptom by Patient Cohort

  48 hours post-dose

Study Arms (2)

Icatibant- Naive Treatment Phase

EXPERIMENTAL

Single subcutaneous injection of icatibant, 30 mg

Drug: Icatibant

icatibant- Self administration Phase

EXPERIMENTAL

Single subcutaneous injection of icatibant, 30 mg

Drug: Icatibant

Interventions

Icatibant DRUG

Single subcutaneous injection of icatibant, 30 mg

Also known as: Brand name, Firazyr®

Icatibant- Naive Treatment Phase; icatibant- Self administration Phase

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.
• Males and females 18 years of age at the time of informed consent
• Documented diagnosis of HAE Type I or II based on ALL of the following criteria:
• Family and/or medical history
• Characteristic attack manifestations, recurrent attacks
• Historical functional C1-INH \<50% normal values
• Women of childbearing potential must use consistently and correctly a highly effective, adequate method of birth control (failure rate less than 1% per year) - sexual abstinence or have a vasectomised partner during the duration of the study. Hormonal contraception can be continued if verified by a physician that it doesn't affect the course of HAE attacks.
• Mental and physical condition allowing patients to complete baseline assessment, to self-administer icatibant and to follow other study procedures.
• Ability to provide signed written informed consent after all aspects of the study have been explained and discussed with the patient.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study.
• Participation in a clinical trial of another investigational medicinal product within the past month (except a previous icatibant study).
• Diagnosis of angioedema other than Type I or Type II HAE.
• Evidence of symptomatic coronary artery disease based on medical history, in particular, unstable angina pectoris or severe coronary heart disease.
• Congestive heart failure (NYHA Class 3 and 4).
• Stroke within the past 6 months.
• Treatment with angiotensin converting enzyme (ACE) inhibitor.
• Pregnancy and/or breast-feeding.
• In the opinion of the investigator: mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
• In the opinion of the investigator: unlikely to comply with the protocol, for example, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study for any reason.
• In the opinion of the investigator: inability to manage study medication or self-administration of an injection.

Sponsors & Collaborators

• Shire: lead
• Jerini AG: collaborator

Study Sites (26)

Hospital Britanico Unidad de Alergia

Buenos Aires, C1035AAT, Argentina

Location

Universitätsklinik für Dermatologie und Venerologie

Graz, 8036, Austria

Location

Odense Universitetshospital-OUH

Odense, I Og Alergicentret, Denmark

Location

Centre Hospitalier Universitaire/ Service de Dermatologie

Angers, Angers Cedex 09, 49933, France

Location

Hospital Edouaed Herriot

Lyon, Cedex 03, 69437, France

Location

Clinique Universitaire de Medicine/ Centre National de reference

Grenoble, Grenoble Cedex 09, 38043, France

Location

Hopital Claude Huriex/ Service de medicine interne

Lille, Lille Cedex, 59037, France

Location

Hopital Europeen Georges Pompidou Immunologie Clinique

Paris, Paris Cedex 15, 75015, France

Location

Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie, Charité

Berlin, 10117, Germany

Location

Universitäts-Hals-Nasen-Ohren-Klinik Essen, Universität Duisburg-Essen

Essen, 45127, Germany

Location

Klinkum der Johann Wolfgang Goethe-Universitat

Frankfurt am Main, 60590, Germany

Location

Hautklinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität

Mainz, 55101, Germany

Location

Bnai-Zion M.C. Clinical Immunology and Allergy Division

Haifa, 31048, Israel

Location

Tel Aviv Sourasky Medical Center - Allergy Unit

Tel Aviv, 64239, Israel

Location

The Chaim Sheba Medical Center, The Allergy and Clinical Immunology Unit

Tel Litwinsky, 52621, Israel

Location

Ospedale Luigi Sacco

Milan, 20157, Italy

Location

Universita degli Studi di Napoli 'Federico II'

Napoli, 80131, Italy

Location

Hospital Universitario Vall de Hebrón / Sección de Alergia, Escola Infermeria

Barcelona, 08035, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitario La Paz, Servicio de Alergia

Madrid, 28046, Spain

Location

Hospital Universitario La Fe, Servicio de Alergia

Valencia, 46009, Spain

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

Universitätsspital Zürich / Dermatologische Klinik

Zurich, 8091, Switzerland

Location

Southmead Hospital, Department of Immunology

Bristol, BS10 5NB, United Kingdom

Location

Barts & The London NHS Trust, Pathology and Pharmacy Building

London, E1 2ES, United Kingdom

Location

Derriford Combined Laboratory, Department of Clinical Immunology & Allergy

Plymouth, PL6 8DH, United Kingdom

Location

Related Publications (1)

• Aberer W, Maurer M, Reshef A, Longhurst H, Kivity S, Bygum A, Caballero T, Bloom B, Nair N, Malbran A. Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema. Allergy. 2014 Mar;69(3):305-14. doi: 10.1111/all.12303.

  PMID: 24438203 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: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2009
• First Posted: October 19, 2009
• Study Start: September 25, 2009
• Primary Completion: June 22, 2011
• Study Completion: June 22, 2011
• Last Updated: June 11, 2021
• Results First Posted: July 28, 2014

Record last verified: 2021-05

Locations

GB (3); AU (1); DK (1); FR (5); IL (3); ES (4); DE (4); CH (2); IT (2); AR (1)