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

Jerini AG0 个研究点目标入组 150 人开始时间: 2009年8月5日最近更新: 2012年3月19日

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•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
•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.

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