Clinical trial NCT05469789: A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)
Official title: Demographic and Clinical Characteristics, Treatment Patterns, and Real-world Effectiveness of Lanadelumab in Patients With Hereditary Angioedema Type I or II in the United Kingdom: an Ambispective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hereditary Angioedema (HAE)
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-07-22
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this survey is all participants with HAE type I or II treated with lanadelumab in hospitals within the UK.

Brief summary: The main aim of this study is to compare the HAE attacks (both total and those requiring on-demand treatment) in the 12 months before and up to 24 months after initiation of treatment 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).


Eligibility criteria: Inclusion:

* Documented diagnosis of HAE type I or II (confirmed through laboratory testing)
* 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

Primary outcomes:
measure: Number of Hereditary Angioedema (HAE) Attacks
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Number of Participants Categorized by Their Demographic Characteristics
timeFrame: At index (lanadelumab treatment initiation day)
measure: Number of Participants Categorized by Their Clinical Characteristics
timeFrame: Up to approximately 3 years
measure: Number of Participants Categorized by Their Treatment Patterns
timeFrame: At and after index (lanadelumab treatment initiation day plus approximately 2 years)
measure: Number of Participants Categorized by Their Patterns of Prophylactic Treatment
timeFrame: Up to approximately 3 years
measure: Compare the Number of Participants Categorized by Their Clinical Features of HAE Attacks Before and After Initiation of Lanadelumab
timeFrame: Up to approximately 3 years
measure: Number of Self-Reported HAE Attacks
timeFrame: Up to approximately 3 years
measure: Number of Participants Categorized by Their Clinical Features of Self-Reported HAE Attacks
timeFrame: Up to approximately 3 years
measure: European Quality of Life 5 Dimensions 3-levels (EQ-5D-3L) Questionnaire Total Score
timeFrame: Up to approximately 2 years
measure: EQ-5D-3L Visual Analogue Scale (VAS) Score
timeFrame: Up to approximately 2 years
measure: Angioedema Quality of Life (AE-QoL) Total Scores
timeFrame: Up to approximately 2 years
measure: Angioedema Quality of Life (AE-QoL) Domain Scores
timeFrame: Up to approximately 2 years
measure: Number of Participants With HAE-related Health Care Resource Utilization (HCRU)
timeFrame: Up to approximately 3 years
measure: Angioedema Control Test (AECT) Total Score
timeFrame: Up to approximately 2 years
measure: Angioedema Control Test (AECT) Domain Score
timeFrame: Up to approximately 2 years
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score
timeFrame: Up to approximately 2 years
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Score
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust
state: England
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: