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NCT06346899 | RECRUITING | Hereditary Angioedema (HAE)


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

Takeda

Brief 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.

Condition or disease

Hereditary Angioedema (HAE)

Intervention/treatment

No intervention

Study Type : OBSERVATIONAL
Estimated Enrollment : 130 participants
Official Title : The Real-World Effectiveness and Safety of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) for Hereditary Angioedema: An Observational Study in China
Actual Study Start Date : 2024-07-20
Estimated Primary Completion Date : 2025-08-13
Estimated Study Completion Date : 2025-08-13

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion criteria
  • * Chinese participants who have received at least one dose of lanadelumab or icatibant from the lanadelumab NMPA approval date (02-Dec-2020) to the date of the day before the 1st site initiation date.
  • * Informed consent will be obtained from the participant (and/or a legally authorized representative) prior to including that participant as a study participant and accessing that participant's data, except for cases in which the informed consent can be waived by the site.
  • 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.

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

Location Details

NCT06346899


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Locations


RECRUITING

China, Furuj

The First Affiliated Hospital of Fujian Medical University

F U-axis, Fujan, China, 350005

RECRUITING

China, Guangdong

The First Affiliated Hospital ,Sun Yat-sen University

Guangzhou, Guangdong, China, 510080

RECRUITING

China, Guangdong

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510260

RECRUITING

China, Henan

Henan Provincial People's Hospital

Zhengzhou, Henan, China, 450003

RECRUITING

China, Hubei

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

Wuhan, Hubei, China, 430030

RECRUITING

China, Liaoning

The First Hospital of China Medical University

Shenyang, Liaoning, China, 110001

RECRUITING

China, Shandong

Qianfo Mountain Hospital, Shandong Province

Women, Shandong, China, 250014

RECRUITING

China, Shanghai

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai, China, 200011

RECRUITING

China, Shanxi

Shanxi Bethune hospital

Taiyuan, Shanxi, China, 030032

RECRUITING

China, Shanxi

The Second Affiliated hospital of Xian Jiaotong University

Xian, Shanxi, China, 710000

RECRUITING

China, Sichuan

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610041

RECRUITING

China, Yunnan

First Affiliated hospital of Kunming Medical University

Kunming, Yunnan, China, 650032

RECRUITING

China, Zhejiang

The Second Affiliated hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310009

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