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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00997204
Other study ID # JE049-3101
Secondary ID 2008-000071-25
Status Completed
Phase Phase 3
First received
Last updated
Start date September 25, 2009
Est. completion date June 22, 2011

Study information

Verified date May 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This Phase IIIb study was multi-center and open-label with a single dose level. Subjects with a documented diagnosis of HAE Type I or II were eligible to participate in this trial. Eligible subjects included those who had received treatment for HAE with icatibant in previous clinical trials, or subjects who had been previously treated with the marketed product Firazyr® and subjects who were naïve to icatibant treatment. All subjects were trained on the method of self-administration at their enrollment visit (Visit 1).For the training sessions, a syringe pre-filled with 3 mL placebo solution was used in place of icatibant. Comprehensive educational material and instructions including pictograms were developed for the subjects to illustrate the method of self-administration and use of the Patient Diary. The training material provided additional information on how to self-diagnose an HAE attack and how to decide on the necessity to treat.In addition, instructions were provided on what to do in case of a laryngeal attack.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Icatibant
Single subcutaneous injection of icatibant, 30 mg

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Shire Jerini AG

Countries where clinical trial is conducted

Argentina,  Austria,  Denmark,  France,  Germany,  Israel,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

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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