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A Study of Lanadelumab in Children With Hereditary Angioedema (HAE) in Multiple Countries
Sponsor: Takeda
Summary
HAE is a rare condition. It causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. This swelling happens because of a temporary leak in blood vessels but does not cause itching or hives. HAE is classified based on the amount of a protein in the blood called C1 inhibitor (C1-INH): HAE with normal C1-INH levels and HAE with limited or insufficient C1-INH levels (C1-INH deficiency). This study will concentrate on children with HAE C1-INH deficiency who have received Takhzyro (Lanadelumab) as prophylactic treatment. The main goal of the study is to assess how well lanadelumab works in children with HAE-C1INH deficiency in everyday life. This will be measured by checking how long children who receive lanadelumab will be free of HAE attacks. Other goals are to understand how children with HAE-C1INH deficiency are being treated with lanadelumab, how well the treatment works for them, how safe it is and how often these children need to use healthcare services (like doctor visits, hospital stays, etc.) because of their condition. The study will only look at data already existing in the participants' medical records. No treatment will be given as part of the study.
Official title: A Multi-national Real-world Outcomes and Treatment Patterns Study of Lanadelumab (Takhzyro) in Paediatric Patients With Hereditary Angioedema (TAHORA)
Key Details
Gender
All
Age Range
2 Years - 11 Years
Study Type
OBSERVATIONAL
Enrollment
40
Start Date
2026-02-05
Completion Date
2026-05-29
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
No intervention
This is a non-interventional study.
Locations (24)
Hospital de Ninos Sor Maria Ludovica
La Plata, Buenos Aires, Argentina
Centro de Alergia e Inmunologia Clinica Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Hospital de Pediatria S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
Ciudad de Buenos Aires, Buenos Aires F.D., Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Ciudad Autonoma de BuenosAires, Argentina
Sanatorio de la Canada-Cordoba
Córdoba, Argentina
AP-HM- Hopital de La Timone
Marseille, Bouches-du-Rhone, France
CHU de Grenoble Alpes - Hopital Couple-Enfant
La Tronche, Grenoble, France
AP-HP - Hopital Armand Trousseau
Paris, France
Universitatsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Universitatsklinikum Frankfurt am Main
Frankfurt am Main, Hesse, Germany
Hamophilie Zentrum Rhein Main GmbH
Frankfurt am Main, Hesse, Germany
Universitatsklinikum Munster
Münster, North Rhine-Westphalia, Germany
Universitatsklinikum Leipzig
Leipzig, Saxony, Germany
Klinikum St. Georg Leipzig
Leipzig, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, Schleswig-Holstein, Germany
Charite Campus Virchow-Klinikum-Augustenburger Platz 1
Berlin, Germany
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem, Israel
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
Petah Tikva, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Childrens University Hospital
Belgrade, Serbia
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, Serbia
Children and Youth Health Care Institute of Vojvodina
Novi Sad, Serbia
Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, United Kingdom
The Royal London Hospital - PPDS
London, United Kingdom