A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China
The Real-World Effectiveness and Safety of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) for Hereditary Angioedema: An Observational Study in China
1 other identifier
observational
115
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2024
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2024
CompletedFirst Posted
Study publicly available on registry
April 4, 2024
CompletedStudy Start
First participant enrolled
July 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedJanuary 21, 2026
January 1, 2026
1 year
March 29, 2024
January 16, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Monthly Rate of HAE Attacks for Each Lanadelumab-treated Participant During the Lanadelumab Exposure Period
The HAE monthly attack rate is defined as the total number of attacks that occurred when the participant was in a lanadelumab exposure period, divided by the total lanadelumab exposure time (in days), multiplied by 28 days.
From the first dose of study drug up to approximately 3 years 8 months
Median Time to Complete Attack Resolution for Icatibant Treated Participants
Time to complete attack resolution among icatibant-treated participants during the retrospective observation period is defined as the time between icatibant first injection and the earliest time of complete resolution of symptoms for each attack during the retrospective observation period that was treated with icatibant.
From the first dose of study drug up to approximately 3 years 8 months
Secondary Outcomes (5)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) During Lanadelumab and Icatibant Exposure Period
From the first dose of study drug up to approximately 3 years 8 months
Dosage of Lanadelumab Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period
From the first dose of study drug up to approximately 3 years 8 months
Frequency Administration of Lanadelumab Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period
From the first dose of study drug up to approximately 3 years 8 months
Number of Participants with Reasons of Discontinuation of Lanadelumab During the Lanadelumab Exposure Period
From the first dose of study drug up to approximately 3 years 8 months
Time to Lanadelumab Discontinuation Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period
From the first dose of study drug up to approximately 3 years 8 months
Study Arms (3)
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.
Interventions
This is a non-interventional study.
Eligibility Criteria
Chinese participants who have received at least one dose of lanadelumab or icatibant from the lanadelumab national medical products administration (NMPA) approval date (02-Dec-2020) to the date of the day before the 1st site initiation date.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (13)
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujan, 350005, China
The First Affiliated Hospital ,Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Tongji Hospital,Tongji Medical College,Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Qianfo Mountain Hospital, Shandong Province
Jinan, Shandong, 250014, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200011, China
Shanxi Bethune hospital
Taiyuan, Shanxi, 030032, China
The Second Affiliated hospital of Xian Jiaotong University
Xian, Shanxi, 710000, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
First Affiliated hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
The Second Affiliated hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2024
First Posted
April 4, 2024
Study Start
July 20, 2024
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.