Actively Recruiting
A Study of Lanadelumab in Children With Hereditary Angioedema (HAE) in Multiple Countries
Led by Takeda · Updated on 2026-05-05
40
Participants Needed
24
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Lanadelumab in Children With Hereditary Angioedema (HAE) in Multiple Countries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 long-term prophylaxis with lanadelumab during the eligibility period.
- Signed consent/assent where required by local regulations.
- Participant's medical record contains documentation of HAE attacks before and after starting lanadelumab.
You will not qualify if you...
- Participant was enrolled in a therapeutic investigational drug or device trial at the time lanadelumab treatment started.
- Participant has no documented HAE attacks in the 12 months before starting lanadelumab.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Hospital de Ninos Sor Maria Ludovica
La Plata, Buenos Aires, Argentina, B1904CSI
Not Yet Recruiting
2
Centro de Alergia e Inmunologia Clinica Mar del Plata
Mar del Plata, Buenos Aires, Argentina, 7600
Not Yet Recruiting
3
Hospital de Pediatria S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
Ciudad de Buenos Aires, Buenos Aires F.D., Argentina, C1249ABN
Not Yet Recruiting
4
Hospital Italiano de Buenos Aires
Buenos Aires, Ciudad Autonoma de BuenosAires, Argentina, C1199ABB
Actively Recruiting
5
Sanatorio de la Canada-Cordoba
Córdoba, Argentina, X5000BSQ
Actively Recruiting
6
AP-HM- Hopital de La Timone
Marseille, Bouches-du-Rhone, France, 13005
Actively Recruiting
7
CHU de Grenoble Alpes - Hopital Couple-Enfant
La Tronche, Grenoble, France, 38700
Actively Recruiting
8
AP-HP - Hopital Armand Trousseau
Paris, France, 75012
Actively Recruiting
9
Universitatsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
Not Yet Recruiting
10
Universitatsklinikum Frankfurt am Main
Frankfurt am Main, Hesse, Germany, 60590
Not Yet Recruiting
11
Hamophilie Zentrum Rhein Main GmbH
Frankfurt am Main, Hesse, Germany, 60596
Actively Recruiting
12
Universitatsklinikum Munster
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
13
Universitatsklinikum Leipzig
Leipzig, Saxony, Germany, 4103
Actively Recruiting
14
Klinikum St. Georg Leipzig
Leipzig, Saxony, Germany, 4129
Actively Recruiting
15
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, Schleswig-Holstein, Germany, 23538
Actively Recruiting
16
Charite Campus Virchow-Klinikum-Augustenburger Platz 1
Berlin, Germany, 13353
Actively Recruiting
17
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem, Israel, 9112001
Actively Recruiting
18
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
Petah Tikva, Israel, 4910000
Actively Recruiting
19
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
20
Childrens University Hospital
Belgrade, Serbia, 11000
Not Yet Recruiting
21
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, Serbia, 11000
Actively Recruiting
22
Children and Youth Health Care Institute of Vojvodina
Novi Sad, Serbia, 21000
Actively Recruiting
23
Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
Actively Recruiting
24
The Royal London Hospital - PPDS
London, United Kingdom, E1 1FR
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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