Hereditary Angioedema (HAE)
Conditions
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.
Interventions
OTHERNo intervention
This is a non-interventional study.
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monthly Rate of HAE Attacks for Each Lanadelumab-treated Participant During the Lanadelumab Exposure Period | From the first dose of study drug up to approximately 3 years 8 months | 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. |
| Median Time to Complete Attack Resolution for Icatibant Treated Participants | From the first dose of study drug up to approximately 3 years 8 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | Dosage of lanadelumab used during the lanadelumab exposure period will be assessed. |
| 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 | Frequency administration of lanadelumab among lanadelumab-treated participant during the lanadelumab exposure period will be assessed. |
| 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 | Number of participants with reasons of discontinuation of lanadelumab during the lanadelumab exposure period will be assessed. |
| 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 | The time to lanadelumab discontinuation is defined as the time from lanadelumab initiation to the first lanadelumab discontinuation. |
Countries
China
Contacts
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed