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. Short title: EASSI Evaluation of the Safety of Self-administration with Icatibant. - EASSI: EvAluation Safety Self-Admini. Icatibant

JERINI AG0 个研究点目标入组 150 人开始时间: 2010年6月8日最近更新: 2012年3月19日

适应症

试验速览

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•1. Males and females ≥18 years of age at the time of informed consent 2. The patient has a documented diagnosis of HAE Type I or II based on ALL of the following criteria: 2a. Family and/or medical history 2b. Characteristic attack manifestations, recurrent attacks 2c. Historical functional C1-INH <50% of normal levels 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 the study aspects have been explained and discussed with 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

•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 medicaI 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 ofthe 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.

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