A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema

• Status: Completed
• Trial end date: 2018-03-12
• Target enrollment: 0
• Participant gender: All

Summary

HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with Hereditary Angioedema (HAE) during an initial acute attack.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Bradykinin; Icatibant

Criteria

Inclusion Criteria:

1. Two through <18 years of age at the time of first HAE attack.

• Prepubertal and pubertal/postpubertal subjects experiencing and 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, but not during an attack.

2. Documented diagnosis of HAE Type I or II.

3. Informed consent (and subject assent as appropriate) signed by the subject's parent(s)or legal guardian(s).

Exclusion Criteria:

1. Diagnosis of angioedema other than HAE.

2. Participation in another clinical trial that involves the 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 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.