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

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/ or immunogenic or functional C1-INH deficiency. Inclusion will be permitted initially based on medical history alone if a clear diagnosis has been made on all of the following criteria:
?Family history;
?Characteristic attack manifestations, recurrent attacks;
?Historical functional C1-INH level < 50%;
?Exclusion of other forms of angioedema;
Subsequent confirmation of the diagnosis is to be made by functional C1-INH measured in the central laboratory. If there are any discrepancies between central and local laboratory results, the patient can only be included in the efficacy analysis if diagnosis of HAE has been clearly confirmed clinically and a rationale for the level of C1-INH > 50% can be given;
•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 and for the duration of the study must use consistently and correctly a highly effective method of birth control (failure rate less than 1% per year), such as implants, injectibles, combined oral contraceptives, reliable intrauterine devices (IUDs), sexual abstinence or vasectomised partner;
•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 before onset of the current angioedema attack;
•Treatment with tranexamic acid therapy within a week before onset of the current angioedema attack;
•Treatment with ACE inhibitors;
•Contraindication for tranexamic acid, i.e. known hypersensitivity to tranexamic acid or any of the ingredients, severe renal failure, active thromboembolic disease, massive bleeding in upper urinary tract, impaired colour vision.
•Evidence of coronary artery disease based on medical history or screening examination, in particular unstable angina pectoris or severe coronary heart disease.
•Congestive heart failure (class 3 and 4)
•Serum creatinine level of > 250µmol/l (>2.82mg/dl)
•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

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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