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Digital Biomarkers Study in Patients with Hereditary Angioedema in Japan: Exploratory Longitudinal Study about Trigger Factors of HAE Attacks

Digital Biomarkers Study in Patients with Hereditary Angioedema in Japan: Exploratory Longitudinal Study about Trigger Factors of HAE Attacks - HAE digital biomarker study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000050129
Enrollment
50
Registered
2023-01-31
Start date
2023-02-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Angioedema (HAE)

Interventions

None listed

Sponsors

Takeda Pharmaceutical Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients who were diagnosed as HAE (Type 1, Type 2, HAE-nC1-INH ) (40 subjects of type 1 or 2, and at most 10 subjects of HAE-nC1-INH) 2.Patients who have experienced two or more attacks of HAE in the past half year from the time of consent 3.Patients aged 12 years or older when providing informed consent 4.Patients judged by the principal investigator or subinvestigator to understand and comply with the study, and to be able to operate the devices 5.Patients who can sign and date the informed consent form by themselves or, if applicable, legally acceptable representatives of the patients prior to the study procedure

Exclusion criteria

Exclusion criteria: 1.Patients who have severe complications (e.g., uncontrolled hypertension, diabetes mellitus, heart failure, etc.) and judged to have difficulty performing normal daily physical activities 2.Patients who have difficulty wearing wearable devices used in this study on a daily basis 3.Patients who are considered ineligible for this study for other reasons by the principal investigator or subinvestigator

Design outcomes

Primary

MeasureTime frame
-Differences in data from various biological data from a wearable device within 48 hours prior to HAE attack and for 48 hours without HAE attack -Correlation coefficients between HAE attack frequency and various data from a wearable device

Secondary

MeasureTime frame
-To examine the occurrence of attacks and associated behaviors -To develop prediction models and investigate the factors that trigger attacks

Countries

Japan

Contacts

Public ContactSuzuki Yuta

Mebix, Inc. Division of research promotion

HAEeCOA_cra@mebix.co.jp03-4362-4504

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026