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.
Study Type
OBSERVATIONAL
Enrollment
115
This is a non-interventional study.
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujan, China
The First Affiliated Hospital ,Sun Yat-sen University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Tongji Hospital,Tongji Medical College,Huazhong University of Science & Technology
Wuhan, Hubei, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Qianfo Mountain Hospital, Shandong Province
Jinan, Shandong, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanxi Bethune hospital
Taiyuan, Shanxi, China
The Second Affiliated hospital of Xian Jiaotong University
Xian, Shanxi, China
...and 3 more locations
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.
Time frame: 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.
Time frame: From the first dose of study drug up to approximately 3 years 8 months
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) During Lanadelumab and Icatibant Exposure Period
An AE is any untoward medical occurrence in a participant administered a studied drug and which does not necessarily have to have a causal relationship with the studied drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a studied drug, whether or not the event is considered causally related to the use of the product. An SAE is any untoward medical occurrence that at any dose: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event in the opinion of the healthcare provider, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
Time frame: 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
Dosage of lanadelumab used during the lanadelumab exposure period will be assessed.
Time frame: 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
Frequency administration of lanadelumab among lanadelumab-treated participant during the lanadelumab exposure period will be assessed.
Time frame: 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
Number of participants with reasons of discontinuation of lanadelumab during the lanadelumab exposure period will be assessed.
Time frame: 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
The time to lanadelumab discontinuation is defined as the time from lanadelumab initiation to the first lanadelumab discontinuation.
Time frame: From the first dose of study drug up to approximately 3 years 8 months
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