A Survey of Lanadelumab in Participants With Hereditary Angioedema

NCT ID: NCT05397431

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-30

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hereditary Angioedema (HAE)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lanadelumab

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

Lanadelumab

Intervention Type DRUG

Lanadelumab 300 mg, subcutaneous injection every 2 weeks

Interventions

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Lanadelumab

Lanadelumab 300 mg, subcutaneous injection every 2 weeks

Intervention Type DRUG

Other Intervention Names

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SHP643 (TAK-743) TAKHZYRO

Eligibility Criteria

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Exclusion Criteria

\- None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Takeda selected site

Tokyo, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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https://clinicaltrials.takeda.com/study-detail/6d5657d5baac48b7

To obtain more information on the study, click here/on this link

Other Identifiers

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jRCT2031220105

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-743-4004

Identifier Type: -

Identifier Source: org_study_id

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