A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)
NCT ID: NCT05469789
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
50 participants
OBSERVATIONAL
2023-06-29
2026-12-31
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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Prevalent Cohort A
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.
No Intervention
As it is an observational study, no intervention is administered in this study.
Prevalent Cohort B
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.
No Intervention
As it is an observational study, no intervention is administered in this study.
Incident Cohort A
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.
No Intervention
As it is an observational study, no intervention is administered in this study.
Interventions
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No Intervention
As it is an observational study, no intervention is administered in this study.
Eligibility Criteria
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Inclusion Criteria
* Documented initiation of treatment with lanadelumab or due to be initiated within next 4 weeks
* 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
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Barts Health NHS Trust
London, England, United Kingdom
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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MACS-2021-0616012
Identifier Type: OTHER
Identifier Source: secondary_id
TAK-743-0001
Identifier Type: -
Identifier Source: org_study_id