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

Hereditary Angioedema (HAE) Clinical Trial

Official title:

The Real-World Effectiveness and Safety of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) for Hereditary Angioedema: An Observational Study in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06346899
• Other study ID #: TAK-743-4012
• Status: Not yet recruiting
• Start date: August 14, 2024
• Est. completion date: August 13, 2025

Study information

• Verified date: May 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: August 13, 2025
• Est. primary completion date: August 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema (HAE)

Intervention

Other:
• No intervention
This is a non-interventional study.

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	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	The Second Affiliated hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Shandong Provincial Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
China	First Affiliated hospital of Kunming Medical University	Kunming	Yunnan
China	Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Shanxi Bethune hospital	Taiyuan	Shanxi
China	Tongji Hospital,Tongji Medical College,Huazhong University of Science & Technology	Wuhan	Hubei
China	The Second Affiliated hospital of Xian Jiaotong University	Xian	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	From the first dose of study drug up to approximately 3 years 8 months
Secondary	Dosage of Lanadelumab Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period	Dosage of lanadelumab used during the lanadelumab exposure period will be assessed.	From the first dose of study drug up to approximately 3 years 8 months
Secondary	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.	From the first dose of study drug up to approximately 3 years 8 months
Secondary	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.	From the first dose of study drug up to approximately 3 years 8 months
Secondary	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.	From the first dose of study drug up to approximately 3 years 8 months