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

• Conditions: Hereditary Angioedema; MedDRA version: 16.0Level: 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-DE
• Lead Sponsor: Shire Orphan Therapies, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-08
• Last Update Posted: 7 May 2018

Recruitment & Eligibility

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

Inclusion Criteria

1. Two to <18 years of age (ie, from the second birthday through the day prior to the eighteenth birthday) at the time of enrollment and treatment with icatibant.
- Prepubertal and pubertal/postpubertal subjects experiencing an acute cutaneous, abdominal, or laryngeal HAE attack treated with icatibant as part of this study.
- Pubertal/postpubertal subjects with HAE who are treated with icatibant as part of this study, but not during an attack.
2. Documented diagnosis of HAE type I or II. Diagnosis may be on the basis of historical data: family history, characteristic attack manifestations, recurrent attacks, historical C1-INH deficiency, and exclusion of other forms of angioedema. Inclusion will be permitted initially based on medical history only if a clear diagnosis has been made based on all of the preceding criteria. However, the diagnosis must be confirmed prior to treatment by documented immunogenic and/or functional C1-INH deficiency (C1-INH protein level below the lower limit of normal and/or functional level <50% of normal) as performed by the Sponsor’s central laboratory.
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: 30
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 or 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 angiotensin converting enzyme (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. Pregnancy 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