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

• Conditions: Hereditary Angioedema (HAE)

• Registration Number: EUCTR2004-001540-71-AT
• Lead Sponsor: Jerini AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-16
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified