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 Angiodema 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

• Conditions: Hereditary Angioedema; MedDRA version: 14.1Level: 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-IT
• Lead Sponsor: SHIRE HUMAN GENETIC THERAPIES, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-19
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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 attack. 2. Documented diagnosis of HAE Type I or II. Diagnosis must be confirmed by documented immunogenic and/or functional C1-INH deficiency results (<50% of normal levels). Diagnosis may be on the basis of historic data or by diagnostic testing conducted at the time of screening. 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 study during the 30 days prior to treatment. 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.

Study & Design

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