A clinical study intended to measure in the bodies of children and adolescents how drug Icatibant is absorbed and removed after a single administration (dose). The children and adolescents in the study will all have the disease called Hereditary Angioedema (which causes abnormal swelling of the body), this is because the drug icatibant is intended to treat Hereditary Angiodema. The study will also look for side effects that may be due to the drug

Phase 1

Active, not recruiting

• Conditions: Hereditary Angioedema; MedDRA version: 23.1Level: PTClassification code 10019860Term: Hereditary angioedemaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2011-003825-81-HU
• Lead Sponsor: Shire Orphan Therapies, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-14
• Study Completion: 2018-03-12
• Last Update Posted: 14 December 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Two through 17 years of age, inclusive (ie, from the second birthday until the day prior to the eighteenth birthday) at the time of the subject’s first HAE attack treated with icatibant as part of this study.
2. Documented diagnosis of HAE Type I or II. Diagnosis must be C1-1NH deficiency (C1-1NH protein level below the lower limit of normal and/or functional level <50% of normal). Diagnosis may be on the basis of historic data or by diagnostic testing conducted at the time of screening. Inclusion will be permitted initially based on medical history only if a clear diagnosis has been made based on all of the following criteria
-Family history
-Characteristic attack manifestations/recurrent attacks
-Historical N1-1NH deficiency as demonstrated by immunologic or functional test results
-Exclusion of other forms of angioedema
-Subsequent confirmation of the diagnosis to be made on the basis of C1-1NH level of function (all subjects)
3. Informed consent (and subject assent as appropriate) signed by the subject’s parent(s) or legal guardian(s).
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diagnosis of angioedema other than HAE.
2. Participation in another clinical trial that involves use of any investigational product (drug of device) within 30 days prior to study enrollment or at any time during the study.
3. Any known factor/disease that might interfere with the treatment compliance, study conduct or result interpretation.
4. Congenital or acquired cardiac anomalies that interfere significantly with cardiac function.
5. Treatment with ACE inhibitors within 7 days prior to treatment.
6. Use of hormonal contraception within the 90 days prior to treatment.
7. Androgen use (eg, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within the 90 days prior to treatment.
8. The subject is pregnant or breastfeeding.
9. A physical condition that interferes with pubertal status determination

Study & Design

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