Status:
RECRUITING
A Study of Lanadelumab in Children With Hereditary Angioedema (HAE) in Multiple Countries
Lead Sponsor:
Takeda
Conditions:
Hereditary Angioedema (HAE)
Eligibility:
All Genders
2-11 years
Brief 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 do...
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Participant was enrolled in a therapeutic investigational drug (lanadelumab or other drug) or device trial at index date.
- Participant with no documented HAE attacks in the 12 months prior to index date.
Key Trial Info
Start Date :
February 5 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 29 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07251933
Start Date
February 5 2026
End Date
May 29 2026
Last Update
February 25 2026
Active Locations (24)
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1
Hospital de Ninos Sor Maria Ludovica
La Plata, Buenos Aires, Argentina, B1904CSI
2
Centro de Alergia e Inmunologia Clinica Mar del Plata
Mar del Plata, Buenos Aires, Argentina, 7600
3
Hospital de Pediatria S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
Ciudad de Buenos Aires, Buenos Aires F.D., Argentina, C1249ABN
4
Hospital Italiano de Buenos Aires
Buenos Aires, Ciudad Autonoma de BuenosAires, Argentina, C1199ABB