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A Multi-national Real-world Outcomes and Treatment Patterns Study of Lanadelumab (Takhzyro) in Paediatric Patients With Hereditary Angioedema (TAHORA)

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 11
Healthy Volunteers: f
View:

• Participant is aged 2 to less than (\<) 12 years at the time of lanadelumab initiation and is expected to have at least 6 months of follow-up information before turning 12.

• Participant has physician-confirmed diagnosis of HAE-C1INH.

• Participant initiated LTP with lanadelumab during the eligibility period.

• Signed consent/assent (where required by local regulations).

• Participant's medical record contains documentation of HAE attacks in the pre-index period and after lanadelumab initiation.

Locations
Other Locations
Argentina
Hospital Italiano de Buenos Aires
NOT_YET_RECRUITING
Buenos Aires
Hospital de Pediatria S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
NOT_YET_RECRUITING
Ciudad De Buenos Aires
Sanatorio de la Canada-Cordoba
NOT_YET_RECRUITING
Córdoba
Hospital de Ninos Sor Maria Ludovica
NOT_YET_RECRUITING
La Plata
Centro de Alergia e Inmunologia Clinica Mar del Plata
NOT_YET_RECRUITING
Mar Del Plata
France
CHU de Grenoble Alpes - Hopital Couple-Enfant
RECRUITING
La Tronche
AP-HM- Hopital de La Timone
RECRUITING
Marseille
AP-HP - Hopital Armand Trousseau
RECRUITING
Paris
Germany
Charite Campus Virchow-Klinikum-Augustenburger Platz 1
NOT_YET_RECRUITING
Berlin
Hamophilie Zentrum Rhein Main GmbH
NOT_YET_RECRUITING
Frankfurt Am Main
Universitatsklinikum Frankfurt am Main
NOT_YET_RECRUITING
Frankfurt Am Main
Klinikum St. Georg Leipzig
NOT_YET_RECRUITING
Leipzig
Universitatsklinikum Leipzig
NOT_YET_RECRUITING
Leipzig
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
NOT_YET_RECRUITING
Lübeck
Universitatsklinikum Munster
NOT_YET_RECRUITING
Münster
Universitatsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Israel
Hadassah Medical Center- Ein Kerem - PPDS
NOT_YET_RECRUITING
Jerusalem
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
NOT_YET_RECRUITING
Petah Tikva
Tel Aviv Sourasky Medical Center
NOT_YET_RECRUITING
Tel Aviv
Serbia
Childrens University Hospital
NOT_YET_RECRUITING
Belgrade
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
NOT_YET_RECRUITING
Belgrade
Children and Youth Health Care Institute of Vojvodina
NOT_YET_RECRUITING
Novi Sad
United Kingdom
The Royal London Hospital - PPDS
NOT_YET_RECRUITING
London
Royal Victoria Infirmary
NOT_YET_RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2026-02-05
Estimated Completion Date: 2026-05-29
Participants
Target number of participants: 40
Treatments
Participants with HAE-C1INH
Paediatric participants with HAE-C1INH who initiated long-term prophylaxis (LTP) treatment with lanadelumab within a routine clinical setting will be included.
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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