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

Completed · Phase 3

Conditions studied: Hereditary Angioedema (HAE)

In brief

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.

Key facts

Study ID

NCT01386658

Run by

Shire

People needed

32

Starts

2012-01-27

Expected to finish

2018-03-12

Last updated by the study team

2021-06-08

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Documented diagnosis of HAE Type I or II.
• Informed consent (and subject assent as appropriate) signed by the subject's parent(s)or legal guardian(s).

You may not qualify if…

• Diagnosis of angioedema other than HAE.
• 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.
• Any known factor/disease that might interfere with the treatment compliance, study conduct,or result interpretation.
• Congenital or acquired cardiac anomalies that interfere significantly with cardiac function.
• Treatment with ACE inhibitors within 7 days prior to treatment.
• Use of hormonal contraception within the 90 days prior to treatment.
• Androgen use (eg, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within the 90 days prior to treatment.
• Pregnancy or breastfeeding.
• A physical condition that interferes with pubertal status determination.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• University of South Florida — Tampa, Florida, United States
• Breathe America — Shreveport, Louisiana, United States
• Institute for Asthma and Allergy, PC — Chevy Chase, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States
• Toledo Institute of Clinical Research — Toledo, Ohio, United States
• Oklahoma Institute of Allergy and Asthma Clinical Research, LLC — Oklahoma City, Oklahoma, United States
• Allergy Asthma Dermatology Research Center — Lake Oswego, Oregon, United States
• Penn State University — Hershey, Pennsylvania, United States
• AARA Research Center — Dallas, Texas, United States
• Campbelltown Hospital — Campbelltown, New South Wales, Australia
• Medizinische Universität Graz Hautklinik — Graz, Austria
• McMaster University — Hamilton, Ontario, Canada
• Hospital Infantil Universitario de San Jose — Bogota, Cundinamarca, Colombia
• Klinikum der Johann Wolfgang Goethe University — Frankfurt, Germany
• Johannes-Gutenberg University Clinical Research Center — Mainz, Germany
• HZRM Hämophilie Zentrum Rhein Main GmbH — Walldorf, Germany
• Heim Pal Childrens Hospital — Budapest, Hungary
• Bnai Zion Medical Center, Allergy and Immunology Institute — Haifa, Israel
• Tel Aviv Sourasky Medical Center, Pulmonology and Allergy Unit — Tel Aviv, Israel
• Sheba Medical Center Allergy and Immunology Angioedema Center — Tel Litwinsky, Israel
• University of Naples Federico II, Dipartimento di Medicina Interna — Naples, Italy
• Unidad de Alergia, Edif. Consultas Externas, Planta Baja HOSPITAL UNIVERSITARIO LA PAZ — Madrid, Spain

Full record on ClinicalTrials.gov

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