The Real-World Effectiveness and Safety of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) for Hereditary Angioedema: An Observational Study in China
Status: Completed
Location: See all (13) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
West China Hospital of Sichuan University
Chengdu
The First Affiliated Hospital of Fujian Medical University
Fuzhou
The First Affiliated Hospital ,Sun Yat-sen University
Guangzhou
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
The Second Affiliated hospital Zhejiang University School of Medicine
Hangzhou
Qianfo Mountain Hospital, Shandong Province
Jinan
First Affiliated hospital of Kunming Medical University
Kunming
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai
The First Hospital of China Medical University
Shenyang
Shanxi Bethune hospital
Taiyuan
Tongji Hospital,Tongji Medical College,Huazhong University of Science & Technology
Wuhan
The Second Affiliated hospital of Xian Jiaotong University
Xian
Henan Provincial People's Hospital
Zhengzhou
Time Frame
Start Date:2024-07-20
Completion Date:2025-07-31
Participants
Target number of participants:115
Treatments
Group L: Lanadelumab
Participants with HAE who have used only lanadelumab during the study-level retrospective observation period will be observed retrospectively from the start date of the participant-level overall baseline period until the end of participant-level retrospective observation period.
Group I: Icatibant
Participants with HAE who have used only icatibant during the study-level retrospective observation period will be observed retrospectively from the start date of the participant-level overall baseline period until the end of participant-level retrospective observation period.
Group B: Lanadelumab + Icatibant
Participants with HAE who have used both lanadelumab and icatibant during the study-level retrospective observation period will be observed retrospectively from the start date of the participant-level overall baseline period until the end of participant-level retrospective observation period.