Clinical trial NCT06346899: A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China
Official title: The Real-World Effectiveness and Safety of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) for Hereditary Angioedema: An Observational Study in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hereditary Angioedema (HAE)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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.

Primary outcomes:
measure: Monthly Rate of HAE Attacks for Each Lanadelumab-treated Participant During the Lanadelumab Exposure Period
timeFrame: From the first dose of study drug up to approximately 3 years 8 months
measure: Median Time to Complete Attack Resolution for Icatibant Treated Participants
timeFrame: From the first dose of study drug up to approximately 3 years 8 months
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) During Lanadelumab and Icatibant Exposure Period
timeFrame: From the first dose of study drug up to approximately 3 years 8 months
measure: Dosage of Lanadelumab Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period
timeFrame: From the first dose of study drug up to approximately 3 years 8 months
measure: Frequency Administration of Lanadelumab Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period
timeFrame: From the first dose of study drug up to approximately 3 years 8 months
measure: Number of Participants with Reasons of Discontinuation of Lanadelumab During the Lanadelumab Exposure Period
timeFrame: From the first dose of study drug up to approximately 3 years 8 months
measure: Time to Lanadelumab Discontinuation Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period
timeFrame: From the first dose of study drug up to approximately 3 years 8 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujan
city: Guangzhou
country: China
facility: The First Affiliated Hospital ,Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital,Tongji Medical College,Huazhong University of Science & Technology
state: Hubei
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qianfo Mountain Hospital, Shandong Province
state: Shandong
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune hospital
state: Shanxi
city: Xian
country: China
facility: The Second Affiliated hospital of Xian Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Kunming
country: China
facility: First Affiliated hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The Second Affiliated hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: