hereditary angioedema, HAE (in adult patients with C1-esterase-inhibitor deficiency) MedDRA version: 12.0 Level: LLT Classification code 10019860 Term: Hereditary angioedema
Conditions
Interventions
Trade Name: Firazyr
Product Name: Icatibant
Product Code: C01EB19
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Icatibant
CAS Number: 13038-48-4
Current Sponsor code: JE049
Concentr
Sponsors
Jerini AG
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 selfadministration of an injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to explore clinical safety with self-treatment of acute HAE attacks with subcutaneous injections of icatibant.;Secondary Objective: The secondary objectives are to determine local tolerability, convenience, and clinical efficacy of self-treatment of HAE attacks with subcutaneous injections of icatibant.;Primary end point(s): The primary endpoint is to show clinical safety with self-treatment of acute HAE attacks with subcutaneous injections of icatibant. | — |
Countries
Austria, Denmark, France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed