Current partner codePEPTIDESDE
NCT00997204·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

151

Locations

26

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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.

Full detailed 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.

Interventions

Treatment arms and agents.

DRUG

Icatibant

Single subcutaneous injection of icatibant, 30 mg

Timeline

From registration to results.

  1. First posted

    Oct 19, 2009

  2. Study start

    Sep 25, 2009

  3. Primary completion

    Jun 22, 2011

  4. Study completion

    Jun 22, 2011

  5. Results posted

    Jul 28, 2014

  6. Registry updated

    Jun 11, 2021

Outcomes

What the study measures.

Primary outcomes

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

Time frame · 7 days from the beginning of each phase

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.

Secondary outcomes

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

Time frame · 48 hours post-dose

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

26 registered sites.

Argentina · Austria · Denmark · France · Germany · Israel · Italy · Spain · Switzerland · United Kingdom. Showing up to 24 locations stored in the fast local snapshot.

Hospital Britanico Unidad de Alergia

Buenos Aires, Argentina

Universitätsklinik für Dermatologie und Venerologie

Graz, Austria

Odense Universitetshospital-OUH

Odense, I Og Alergicentret, Denmark

Centre Hospitalier Universitaire/ Service de Dermatologie

Angers, Angers Cedex 09, France

Hospital Edouaed Herriot

Lyon, Cedex 03, 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

Hopital Europeen Georges Pompidou Immunologie Clinique

Paris, Paris Cedex 15, France

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, Germany

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 Litwinsky, Israel

Ospedale Luigi Sacco

Milan, Italy

Universita degli Studi di Napoli 'Federico II'

Naples, Italy

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, Spain

Luzerner Kantonsspital

Lucerne, Switzerland

Universitätsspital Zürich / Dermatologische Klinik

Zurich, Switzerland

Southmead Hospital, Department of Immunology

Bristol, United Kingdom

Related trials

More studies on Icatibant.

Related PeptideStat pages

Put the record in context.

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