A Survey of Lanadelumab in Participants With Hereditary Angioedema

Takeda155 enrolled

Overview

This study is a survey in Japan of Lanadelumab used to treat people with hereditary angioedema (HAE). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related from Lanadelumab and to check if Lanadelumab improves symptoms of HAE. During the study, participants with HAE will take Lanadelumab subcutaneous injection according to their clinic's standard practice. The study doctors will check for side effects from Lanadelumab for 12 months.

Study Type

OBSERVATIONAL

Enrollment

155

Conditions

Hereditary Angioedema (HAE)

Interventions

LanadelumabDRUG

Lanadelumab 300 mg, subcutaneous injection every 2 weeks

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria - Participants diagnosed with hereditary angioedema (HAE) and treated with Lanadelumab for the first time. Exclusion Criteria \- None

Locations (1)

Takeda selected site

Tokyo, Tokyo, Japan

Outcomes

Primary Outcomes

Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)

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.

Time frame: 12 Months

Secondary Outcomes

Number of Angioedema Attacks

Number of angioedema attacks during the study will be assessed.

Time frame: 12 Months

Angioedema Quality of life (AE-QoL) Questionnaire

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).

Time frame: 12 Months

Data from ClinicalTrials.gov

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