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

PHASE3CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

January 27, 2012

Primary Completion Date

March 12, 2018

Study Completion Date

March 12, 2018

Conditions
Hereditary Angioedema (HAE)
Interventions
DRUG

icatibant

Single dose of icatibant 0.4 mg/kg subcutaneous(SC) up to a maximal dose of 30 mg

Trial Locations (26)

2560

Campbelltown Hospital, Campbelltown

8036

Medizinische Universität Graz Hautklinik, Graz

17033

Penn State University, Hershey

20815

Institute for Asthma and Allergy, PC, Chevy Chase

28046

Unidad de Alergia, Edif. Consultas Externas, Planta Baja HOSPITAL UNIVERSITARIO LA PAZ, Madrid

33613

University of South Florida, Tampa

43617

Toledo Institute of Clinical Research, Toledo

45231

Bernstein Clinical Research Center, LLC, Cincinnati

46026

University Hospital, Pediatric Pulmonology and Allergy Unit, Valencia

52621

Sheba Medical Center Allergy and Immunology Angioedema Center, Tel Litwinsky

55131

Johannes-Gutenberg University Clinical Research Center, Mainz

60590

Klinikum der Johann Wolfgang Goethe University, Frankfurt

63141

Washington University School of Medicine, St Louis

64239

Tel Aviv Sourasky Medical Center, Pulmonology and Allergy Unit, Tel Aviv

64546

HZRM Hämophilie Zentrum Rhein Main GmbH, Walldorf

71106

Breathe America, Shreveport

73131

Oklahoma Institute of Allergy and Asthma Clinical Research, LLC, Oklahoma City

75231

AARA Research Center, Dallas

80131

University of Naples Federico II, Dipartimento di Medicina Interna, Naples

90027

Children's Hospital Los Angeles, Los Angeles

97035

Allergy Asthma Dermatology Research Center, Lake Oswego

02115

Boston Children's Hospital, Boston

L8S 4K1

McMaster University, Hamilton

Unknown

Hospital Infantil Universitario de San Jose, Bogota

Bnai Zion Medical Center, Allergy and Immunology Institute, Haifa

H-1131

Heim Pal Childrens Hospital, Budapest

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT01386658 - A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema | Biotech Hunter | Biotech Hunter