Actively Recruiting

Age: 2Years - 11Years
All Genders
NCT07251933

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

Age: 2Years - 11Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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

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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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A Study of Lanadelumab in Children With Hereditary Angioedema (HAE) in Multiple Countries | DecenTrialz