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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05397431
Other study ID # TAK-743-4004
Secondary ID jRCT2031220105
Status Recruiting
Phase
First received
Last updated
Start date May 30, 2022
Est. completion date August 31, 2026

Study information

Verified date July 2023
Source Takeda
Contact Takeda Contact
Phone +1-877-825-3327
Email medinfoUS@takeda.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 31, 2026
Est. primary completion date August 31, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria - Participants diagnosed with hereditary angioedema (HAE) and treated with Lanadelumab for the first time. Exclusion Criteria - None

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lanadelumab
Lanadelumab 300 mg, subcutaneous injection every 2 weeks

Locations

Country Name City State
Japan Takeda selected site Tokyo T

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 Months
Secondary Number of Angioedema Attacks Number of angioedema attacks during the study will be assessed. 12 Months
Secondary 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). 12 Months
See also
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Completed NCT02584959 - Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema Phase 3
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