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

Last updated: February 23, 2026
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

No intervention

Clinical Study ID

NCT07251933
TAK-743-4038
  • Ages 2-11
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Participant is aged 2 to less than (<) 12 years at the time of lanadelumabinitiation and is expected to have at least 6 months of follow-up information beforeturning 12.

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

  3. Participant initiated LTP with lanadelumab during the eligibility period.

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

  5. Participant's medical record contains documentation of HAE attacks in the pre-indexperiod and after lanadelumab initiation.

Exclusion

Exclusion Criteria:

  1. Participant was enrolled in a therapeutic investigational drug (lanadelumab or otherdrug) or device trial at index date.

  2. Participant with no documented HAE attacks in the 12 months prior to index date.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
February 05, 2026
Estimated Completion Date:
May 29, 2026

Connect with a study center

  • Hospital de Ninos Sor Maria Ludovica

    La Plata 3432043, Buenos Aires 3435907 B1904CSI
    Argentina

    Site Not Available

  • Centro de Alergia e Inmunologia Clinica Mar del Plata

    Mar del Plata 3430863, Buenos Aires 3435907 7600
    Argentina

    Site Not Available

  • Hospital de Pediatria S.A.M.I.C.- Prof. Dr. Juan P. Garrahan

    Ciudad de Buenos Aires, Buenos Aires F.D. 3433955 C1249ABN
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    Buenos Aires 3435910, Ciudad Autonoma de BuenosAires C1199ABB
    Argentina

    Site Not Available

  • Sanatorio de la Canada-Cordoba

    Córdoba 3860259, X5000BSQ
    Argentina

    Site Not Available

  • AP-HM- Hopital de La Timone

    Marseille 2995469, Bouches-du-Rhone 13005
    France

    Active - Recruiting

  • CHU de Grenoble Alpes - Hopital Couple-Enfant

    La Tronche 3006131, Grenoble 38700
    France

    Active - Recruiting

  • AP-HP - Hopital Armand Trousseau

    Paris 2988507, 75012
    France

    Active - Recruiting

  • Universitatsklinikum Ulm

    Ulm 2820256, Baden-Wurttemberg 2953481 89081
    Germany

    Site Not Available

  • Hamophilie Zentrum Rhein Main GmbH

    Frankfurt am Main 2925533, Hesse 2905330 60596
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt am Main

    Frankfurt am Main 2925533, Hesse 2905330 60590
    Germany

    Site Not Available

  • Universitatsklinikum Munster

    Münster 2867543, North Rhine-Westphalia 2861876 48149
    Germany

    Site Not Available

  • Klinikum St. Georg Leipzig

    Leipzig 2879139, Saxony 2842566 4129
    Germany

    Site Not Available

  • Universitatsklinikum Leipzig

    Leipzig 2879139, Saxony 2842566 4103
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck 2875601, Schleswig-Holstein 2838632 23538
    Germany

    Site Not Available

  • Charite Campus Virchow-Klinikum-Augustenburger Platz 1

    Berlin 2950159, 13353
    Germany

    Site Not Available

  • Hadassah Medical Center- Ein Kerem - PPDS

    Jerusalem 281184, 9112001
    Israel

    Site Not Available

  • Schneider Childrens Medical Center of Israel Petah Tikvah PIN

    Petah Tikva 293918, 4910000
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv 293397, 6423906
    Israel

    Site Not Available

  • Childrens University Hospital

    Belgrade 792680, 11000
    Serbia

    Site Not Available

  • Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

    Belgrade 792680, 11000
    Serbia

    Site Not Available

  • Children and Youth Health Care Institute of Vojvodina

    Novi Sad 3194360, 21000
    Serbia

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle upon Tyne 2641673, Tyne and Wear NE1 4LP
    United Kingdom

    Site Not Available

  • The Royal London Hospital - PPDS

    London 2643743, E1 1FR
    United Kingdom

    Site Not Available

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