A Survey of Lanadelumab in Participants with Hereditary Angioedema
Not Applicable
Recruiting
- Conditions
- Hereditary Angioedema
- Registration Number
- JPRN-jRCT2031220105
- Lead Sponsor
- Contact for Clinical Trial Information
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Participants diagnosed with hereditary angioedema (HAE) and treated with Lanadelumab for the first time.
Exclusion Criteria
Not Applicable
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)<br>Time Frame: 12 Months<br>An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product. An adverse event does not necessarily have a causal relationship with the intervention. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
- Secondary Outcome Measures
Name Time Method 1.Number of Angioedema Attacks <br>Time Frame: 12 Months<br>Number of angioedema attacks during the study will be assessed.<br><br>2.Angioedema Quality of life (AE-QoL) Questionnaire<br>Time Frame: 12 Months<br>The AE-QoL questionnaire is a self-administered validated instrument to assess health related (HR)QoL among participants with recurrent angioedema (including HAE). The AE-QoL consists of 17 disease-specific quality-of-life items, to produce a total AE-QoL score and 4 domain scores (functioning, fatigue/mood, fear/shame, and nutrition) and each of the 17 items has a five-point response scale ranging from 1 (Never) to 5 (Very Often).