EASSI - Evaluation of the Safety of Self-Administration With Icatibant
This trial is active, not recruiting.
|Start date||September 2009|
|End date||January 2011|
|Trial size||150 participants|
|Trial identifier||NCT00997204, JE049-3101|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Buenos Aires, Argentina||Hospital Britanico Unidad de Alergia||no longer recruiting|
|Graz, Austria||Universitätsklinik für Dermatologie und Venerologie||no longer recruiting|
|Odense, Denmark||Odense Universitetshospital-OUH||no longer recruiting|
|Angers, France||Centre Hospitalier Universitaire/ Service de Dermatologie||no longer recruiting|
|Lyon, France||Hospital Edouaed Herriot||no longer recruiting|
|Grenoble, France||Clinique Universitaire de Medicine/ Centre National de reference||no longer recruiting|
|Lille, France||Hopital Claude Huriex/ Service de medicine interne||no longer recruiting|
|Paris, France||Hopital Europeen Georges Pompidou Immunologie Clinique||no longer recruiting|
|Berlin, Germany||Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie, Charité||no longer recruiting|
|Essen, Germany||Universitäts-Hals-Nasen-Ohren-Klinik Essen, Universität Duisburg-Essen||no longer recruiting|
|Frankfurt am Main, Germany||Klinkum der Johann Wolfgang Goethe-Universitat||no longer recruiting|
|Mainz, Germany||Hautklinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität||no longer recruiting|
|Haifa, Israel||Bnai-Zion M.C. Clinical Immunology and Allergy Division||no longer recruiting|
|Tel Aviv, Israel||Tel Aviv Sourasky Medical Center - Allergy Unit||no longer recruiting|
|Tel Hashomer, Israel||The Chaim Sheba Medical Center, The Allergy and Clinical Immunology Unit||no longer recruiting|
|Milano, Italy||Ospedale Luigi Sacco||no longer recruiting|
|Napoli,, Italy||Universita degli Studi di Napoli 'Federico II'||no longer recruiting|
|Barcelona, Spain||Hospital Universitario Vall de Hebrón / Sección de Alergia, Escola Infermeria||no longer recruiting|
|Madrid, Spain||Hospital General Universitario Gregorio Maranon||no longer recruiting|
|Madrid, Spain||Hospital Universitario La Paz, Servicio de Alergia||no longer recruiting|
|Valencia, Spain||Hospital Universitario La Fe, Servicio de Alergia||no longer recruiting|
|Luzern, Switzerland||Luzerner Kantonsspital||no longer recruiting|
|Zurich, Switzerland||Universitätsspital Zürich / Dermatologische Klinik||no longer recruiting|
|Bristol, United Kingdom||Southmead Hospital, Department of Immunology||no longer recruiting|
|London, United Kingdom||Barts & The London NHS Trust, Pathology and Pharmacy Building||no longer recruiting|
|Plymouth, United Kingdom||Derriford Combined Laboratory, Department of Clinical Immunology & Allergy||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Single subcutaneous injection of icatibant, 30 mg
Clinical safety of self-treatment of acute HAE attacks with s.c. injections of icatibant
time frame: 48 hours post-dose
Local tolerability, convenience, and clinical efficacy of self-treatment of acute HAE attacks with s.c. injections of icatibant.
time frame: 48 hours post-dose
Male or female participants at least 18 years old.
- 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.
- 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.
|Official title||Open Label, Multicenter Study to Evaluate Safety, Local Tolerability, Convenience, and Efficacy of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema|
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