Randomised, double blind, controlled, parallel group, multicentre study of a subcutaneous formulation of Icatibant vs. oral Tranexamic acid for the treatment of hereditary angioedema (HAE). - FAST 2

Jerini AG0 个研究点开始时间: 2004年12月14日最近更新: 2012年3月19日

研究概览

暂无简介。

•Age ? 18 years;
•Documented diagnosis of HAE Type I or II (confirmed by medical history and C1-INH deficiency);
•Current angioedema attack must be in the cutaneous, abdominal and/or laryngeal areas;
•Current attack must be moderate to very severe
•Able to complete baseline assessments, and commence treatment no later than 6 hours after the time the current attack becomes moderate;
•Women of childbearing potential must have a negative urine pregnancy test;
•Signed written Informed Consent given.
•Patients with abdominal and/or cutaneous symptoms only:
•VAS (Visual Analogue Scale) for primary symptoms (abdominal pain, or cutaneous pain or swelling) at time of randomization ? 30 mm
•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

•Diagnosis of angioedema other than HAE, for example, acquired angioedema (AAE);
•Participation in a clinical trial of another investigational medicinal product (IMP) within the past month;
•Treatment with any pain medication since onset of the current angioedema attack;
•Treatment with replacement therapy, including C1-INH products, less than 3 days from onset of the current angioedema attack;
•Treatment with ACE inhibitors;
•Contraindication for tranexamic acid
•Evidence of severe, symptomatic coronary artery disease based on medical history or screening examination;
•Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial;
•Pregnancy and/or breast-feeding;
•Mental condition rendering the patients, in the opinion of the investigator, unable to understand the nature, scope and possible consequences of the study;
•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

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