Hereditary Angioedema Clinical Trial
— EASSIOfficial 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
Verified date | May 2021 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 151 |
Est. completion date | June 22, 2011 |
Est. primary completion date | June 22, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Each patient must meet the following criteria to be enrolled in this study. 1. Males and females 18 years of age at the time of informed consent 2. 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 3. 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. 4. Mental and physical condition allowing patients to complete baseline assessment, to self-administer icatibant and to follow other study procedures. 5. Ability to provide signed written informed consent after all aspects of the study have been explained and discussed with the patient. Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study. 1. Participation in a clinical trial of another investigational medicinal product within the past month (except a previous icatibant study). 2. Diagnosis of angioedema other than Type I or Type II HAE. 3. Evidence of symptomatic coronary artery disease based on medical history, in particular, unstable angina pectoris or severe coronary heart disease. 4. Congestive heart failure (NYHA Class 3 and 4). 5. Stroke within the past 6 months. 6. Treatment with angiotensin converting enzyme (ACE) inhibitor. 7. Pregnancy and/or breast-feeding. 8. In the opinion of the investigator: mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study. 9. 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. 10. In the opinion of the investigator: inability to manage study medication or self-administration of an injection. |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Britanico Unidad de Alergia | Buenos Aires | |
Austria | Universitätsklinik für Dermatologie und Venerologie | Graz | |
Denmark | Odense Universitetshospital-OUH | Odense | I Og Alergicentret |
France | Centre Hospitalier Universitaire/ Service de Dermatologie | Angers | Angers Cedex 09 |
France | Clinique Universitaire de Medicine/ Centre National de reference | Grenoble | Grenoble Cedex 09 |
France | Hopital Claude Huriex/ Service de medicine interne | Lille | Lille Cedex |
France | Hospital Edouaed Herriot | Lyon | Cedex 03 |
France | Hopital Europeen Georges Pompidou Immunologie Clinique | Paris | Paris Cedex 15 |
Germany | Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie, Charité | Berlin | |
Germany | Universitäts-Hals-Nasen-Ohren-Klinik Essen, Universität Duisburg-Essen | Essen | |
Germany | Klinkum der Johann Wolfgang Goethe-Universitat | Frankfurt am Main | |
Germany | Hautklinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität | Mainz | |
Israel | Bnai-Zion M.C. Clinical Immunology and Allergy Division | Haifa | |
Israel | Tel Aviv Sourasky Medical Center - Allergy Unit | Tel Aviv | |
Israel | The Chaim Sheba Medical Center, The Allergy and Clinical Immunology Unit | Tel Hashomer | |
Italy | Ospedale Luigi Sacco | Milano | |
Italy | Universita degli Studi di Napoli 'Federico II' | Napoli, | |
Spain | Hospital Universitario Vall de Hebrón / Sección de Alergia, Escola Infermeria | Barcelona | |
Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
Spain | Hospital Universitario La Paz, Servicio de Alergia | Madrid | |
Spain | Hospital Universitario La Fe, Servicio de Alergia | Valencia | |
Switzerland | Luzerner Kantonsspital | Luzern | |
Switzerland | Universitätsspital Zürich / Dermatologische Klinik | Zurich | |
United Kingdom | Southmead Hospital, Department of Immunology | Bristol | |
United Kingdom | Barts & The London NHS Trust, Pathology and Pharmacy Building | London | |
United Kingdom | Derriford Combined Laboratory, Department of Clinical Immunology & Allergy | Plymouth |
Lead Sponsor | Collaborator |
---|---|
Shire | Jerini AG |
Argentina, Austria, Denmark, France, Germany, Israel, Italy, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | Subjects assessed angioedema attack symptoms using the visual analogue scale (VAS) for skin pain, skin swelling and abdominal pain. The VAS is a continuous scale comprised of a 100 mm in length line, anchored by 2 verbal descriptors, one for each symptom extreme 0 (no pain) and 100 (worst pain). The respondent is asked to place a mark on the VAS line (any where between 0 and 100 mm) at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Score interpretation is: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). Symptom relief is defined as at least a 50% reduction in a pre-dose VAS score of 30 mm or greater. The time to onset of symptom relief is defined as the first of 3 consecutive assessments at which symptom relief was observed. | 48 hours post-dose |
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