A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China

Last updated: August 8, 2025
Sponsor: Takeda
Overall Status: Completed

Phase

N/A

Condition

Hives (Urticaria)

Allergy

Allergies & Asthma

Treatment

No intervention

Clinical Study ID

NCT06346899
TAK-743-4012
  • All Genders

Study Summary

The Chinese health authority has approved lanadelumab to prevent Hereditary Angioedema (HAE) attacks in persons of 12 years and older. It has also approved icatibant to treat acute HAE attacks in persons 2 years and older.

One of the main aims of this study is to learn about the number of HAE attacks in 1 month in Chinese persons with HAE during their treatment with lanadelumab. The other main aim is to learn how much time is needed to resolve acute HAE attacks when treated with icatibant. Other aims of this study are to learn more about side effects of lanadelumab and icatibant treatment as well as to collect additional information on the treatment with lanadelumab, such as the dose and how often it needs to be given, reasons for stopping the treatment with lanadelumab and how long it was taken until stopping. Participants will be treated by their doctors according to routine medical practice. Only data already available in the medical records of the participants will be reviewed and collected during this study.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Chinese participants who have received at least one dose of lanadelumab or icatibantfrom the lanadelumab NMPA approval date (02-Dec-2020) to the date of the day beforethe 1st site initiation date.

  • Informed consent will be obtained from the participant (and/or a legally authorizedrepresentative) prior to including that participant as a study participant andaccessing that participant's data, except for cases in which the informed consentcan be waived by the site.

Exclusion

Exclusion criteria:

• Participation in other interventional studies involving lanadelumab, icatibant, or any other HAE drug or investigational product on or after the date of the participant's lanadelumab or icatibant initiation.

Study Design

Total Participants: 115
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
July 20, 2024
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujan 350005
    China

    Site Not Available

  • The First Affiliated Hospital ,Sun Yat-sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510260
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • Tongji Hospital,Tongji Medical College,Huazhong University of Science & Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • Qianfo Mountain Hospital, Shandong Province

    Jinan, Shandong 250014
    China

    Site Not Available

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong 250021
    China

    Site Not Available

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200011
    China

    Site Not Available

  • Shanxi Bethune hospital

    Taiyuan, Shanxi 030032
    China

    Site Not Available

  • The Second Affiliated hospital of Xian Jiaotong University

    Xian, Shanxi 710000
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • First Affiliated hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Site Not Available

  • The Second Affiliated hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

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