A Survey of Lanadelumab in Participants With Hereditary Angioedema

Sponsor
Takeda (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05397431
Collaborator
(none)
100
1
51.1
2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Specific Use-Results Survey of TAKHZYRO Subcutaneous Injection 300 mg Syringe for Hereditary Angioedema With Long-term Administration
Actual Study Start Date :
May 30, 2022
Anticipated Primary Completion Date :
Aug 31, 2026
Anticipated Study Completion Date :
Aug 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Lanadelumab

Participants will receive 300 milligram (mg) of Lanadelumab Subcutaneous (SC) injection once every 2 weeks.

Drug: Lanadelumab
Lanadelumab 300 mg, subcutaneous injection every 2 weeks
Other Names:
  • SHP643 (TAK-743)
  • TAKHZYRO
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE) [12 Months]

      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

    1. Number of Angioedema Attacks [12 Months]

      Number of angioedema attacks during the study will be assessed.

    2. Angioedema Quality of life (AE-QoL) Questionnaire [12 Months]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria - Participants diagnosed with hereditary angioedema (HAE) and treated with Lanadelumab for the first time.

    Exclusion Criteria

    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Takeda selected site Tokyo T Japan

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT05397431
    Other Study ID Numbers:
    • TAK-743-4004
    • jRCT2031220105
    First Posted:
    May 31, 2022
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 29, 2022