A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)

Takeda

Status: Enrolling

Conditions: Hereditary Angioedema (HAE)

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05469789

MACS-2021-0616012 (Other Identifier)

TAK-743-0001

Details and patient eligibility

About

The main aim of this study is to compare the HAE attack rate requiring on-demand treatment before and within 2 years after participants with HAE have been treated with lanadelumab.

This study is conducted in the United Kingdom where participants were treated or about to be treated with landelumab according to their routine practice at hospitals. Data will be directly collected from participants via study diaries, questionnaires, their medical records, and study doctors treating them. Participants will be contacted every 3 months during study participation (via phone).

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Documented diagnosis of HAE type I or II (confirmed through laboratory testing)
• Documented initiation of treatment with lanadelumab
• Greater than or equal to (≥)12 years of age at initiation of treatment with lanadelumab
• ≥12 months of continuous medical record data before initiation of treatment with lanadelumab

Exclusion:

• Exposure to lanadelumab administered as an investigation product in a clinical trial setting at any point in time

Trial design

50 participants in 3 patient groups

Prevalent Cohort A

Description:

Prevalent Cohort A will comprise eligible participants with HAE type I or II who have initiated treatment with lanadelumab at any point in time (i.e., all prevalent cases of exposure to lanadelumab). The total follow-up encompasses a 12-month pre-treatment period, and an up-to 24-month post-treatment period.

Treatment:

Other: No Intervention

Prevalent Cohort B

Description:

Prevalent Cohort B will comprise eligible participants with HAE type I or II who have been treated with lanadelumab for \<12 months (i.e., the subset of participants from Prevalent Cohort A who initiated treatment with lanadelumab within \<12 months). The total follow-up encompasses a 12-month pre-treatment and an up to 24-month post-treatment period, as well as a prospective data collection period of participant-specific duration.

Treatment:

Other: No Intervention

Incident Cohort A

Description:

Incident Cohort A will comprise eligible participants with HAE type I or II initiating treatment with lanadelumab at any time within the prospective data collection time period. The total follow-up encompasses a 12-month pre-treatment and an up-to 24-month post-treatment period, as well as a prospective data collection period of participant-specific duration.

Treatment:

Other: No Intervention