Status:
COMPLETED
EASSI - Evaluation of the Safety of Self-Administration With Icatibant
Lead Sponsor:
Shire
Collaborating Sponsors:
Jerini AG
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2011
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00997204
Start Date
September 25 2009
End Date
June 22 2011
Last Update
June 11 2021
Active Locations (26)
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1
Hospital Britanico Unidad de Alergia
Buenos Aires, Argentina, C1035AAT
2
Universitätsklinik für Dermatologie und Venerologie
Graz, Austria, 8036
3
Odense Universitetshospital-OUH
Odense, I Og Alergicentret, Denmark
4
Centre Hospitalier Universitaire/ Service de Dermatologie
Angers, Angers Cedex 09, France, 49933