Back to resultsEASSI - Evaluation of the Safety of Self-Administration With Icatibant (EASSI)
Primary Purpose
Hereditary Angioedema
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Icatibant
Sponsored by
About this trial
This is an interventional treatment trial for Hereditary Angioedema focused on measuring HAE, Type I HAE, Type II HAE
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Sites / Locations
- Hospital Britanico Unidad de Alergia
- Universitätsklinik für Dermatologie und Venerologie
- Odense Universitetshospital-OUH
- Centre Hospitalier Universitaire/ Service de Dermatologie
- Hospital Edouaed Herriot
- Clinique Universitaire de Medicine/ Centre National de reference
- Hopital Claude Huriex/ Service de medicine interne
- Hopital Europeen Georges Pompidou Immunologie Clinique
- Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie, Charité
- Universitäts-Hals-Nasen-Ohren-Klinik Essen, Universität Duisburg-Essen
- Klinkum der Johann Wolfgang Goethe-Universitat
- Hautklinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität
- Bnai-Zion M.C. Clinical Immunology and Allergy Division
- Tel Aviv Sourasky Medical Center - Allergy Unit
- The Chaim Sheba Medical Center, The Allergy and Clinical Immunology Unit
- Ospedale Luigi Sacco
- Universita degli Studi di Napoli 'Federico II'
- Hospital Universitario Vall de Hebrón / Sección de Alergia, Escola Infermeria
- Hospital General Universitario Gregorio Maranon
- Hospital Universitario La Paz, Servicio de Alergia
- Hospital Universitario La Fe, Servicio de Alergia
- Luzerner Kantonsspital
- Universitätsspital Zürich / Dermatologische Klinik
- Southmead Hospital, Department of Immunology
- Barts & The London NHS Trust, Pathology and Pharmacy Building
- Derriford Combined Laboratory, Department of Clinical Immunology & Allergy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Icatibant- Naive Treatment Phase
icatibant- Self administration Phase
Arm Description
Single subcutaneous injection of icatibant, 30 mg
Single subcutaneous injection of icatibant, 30 mg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00997204
First Posted
October 16, 2009
Last Updated
June 1, 2021
Sponsor
Shire
Collaborators
Jerini AG
1. Study Identification
Unique Protocol Identification Number
NCT00997204
Brief Title
EASSI - Evaluation of the Safety of Self-Administration With Icatibant
Acronym
EASSI
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 25, 2009 (Actual)
Primary Completion Date
June 22, 2011 (Actual)
Study Completion Date
June 22, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
Collaborators
Jerini AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Angioedema
Keywords
HAE, Type I HAE, Type II HAE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Icatibant- Naive Treatment Phase
Arm Type
Experimental
Arm Description
Single subcutaneous injection of icatibant, 30 mg
Arm Title
icatibant- Self administration Phase
Arm Type
Experimental
Arm Description
Single subcutaneous injection of icatibant, 30 mg
Intervention Type
Drug
Intervention Name(s)
Icatibant
Other Intervention Name(s)
Brand name, Firazyr®
Intervention Description
Single subcutaneous injection of icatibant, 30 mg
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant
Description
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.
Time Frame
7 days from the beginning of each phase
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
48 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Britanico Unidad de Alergia
City
Buenos Aires
ZIP/Postal Code
C1035AAT
Country
Argentina
Facility Name
Universitätsklinik für Dermatologie und Venerologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Odense Universitetshospital-OUH
City
Odense
State/Province
I Og Alergicentret
Country
Denmark
Facility Name
Centre Hospitalier Universitaire/ Service de Dermatologie
City
Angers
State/Province
Angers Cedex 09
ZIP/Postal Code
49933
Country
France
Facility Name
Hospital Edouaed Herriot
City
Lyon
State/Province
Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
Clinique Universitaire de Medicine/ Centre National de reference
City
Grenoble
State/Province
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Claude Huriex/ Service de medicine interne
City
Lille
State/Province
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Europeen Georges Pompidou Immunologie Clinique
City
Paris
State/Province
Paris Cedex 15
ZIP/Postal Code
75015
Country
France
Facility Name
Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie, Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitäts-Hals-Nasen-Ohren-Klinik Essen, Universität Duisburg-Essen
City
Essen
ZIP/Postal Code
45127
Country
Germany
Facility Name
Klinkum der Johann Wolfgang Goethe-Universitat
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Hautklinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Bnai-Zion M.C. Clinical Immunology and Allergy Division
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center - Allergy Unit
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
The Chaim Sheba Medical Center, The Allergy and Clinical Immunology Unit
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Ospedale Luigi Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Universita degli Studi di Napoli 'Federico II'
City
Napoli,
ZIP/Postal Code
80131
Country
Italy
Facility Name
Hospital Universitario Vall de Hebrón / Sección de Alergia, Escola Infermeria
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario La Paz, Servicio de Alergia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario La Fe, Servicio de Alergia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Luzerner Kantonsspital
City
Luzern
Country
Switzerland
Facility Name
Universitätsspital Zürich / Dermatologische Klinik
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Southmead Hospital, Department of Immunology
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Barts & The London NHS Trust, Pathology and Pharmacy Building
City
London
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Facility Name
Derriford Combined Laboratory, Department of Clinical Immunology & Allergy
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24438203
Citation
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.
Results Reference
derived
Learn more about this trial
EASSI - Evaluation of the Safety of Self-Administration With Icatibant
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