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 - EASSI - Evaluation of the Safety of Self-administration with Icatibant
- Conditions
- hereditary angioedema, HAE (in adult patients with C1-esterase-inhibitor deficiency)MedDRA version: 12.0Level: LLTClassification code 10019860Term: Hereditary angioedema
- Registration Number
- EUCTR2008-000071-25-FR
- Lead Sponsor
- Jerini AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 selfadministration of an injection.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method