Assessment of the utility of Hoesch test assay as initial screening test for acute hepatic porphyria in Japan

Assessment of the utility of Hoesch test assay as initial screening test for acute hepatic porphyria in Japan - Assessment of the utility of Hoesch test assay as initial screening test for acute hepatic porphyria in Japan

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054495

Enrollment

1000

Registered

2024-05-28

Start date

2024-05-01

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

acute hepatic porphyria

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients meeting the definition of NSAP who are seen at each practitioner's office, who are under 65 years of age at the time of their first visit, and who are suspected of having AHP.

Exclusion criteria

Exclusion criteria: (1) Persons 65 years of age or older (2) Persons who do not plan to perform the quantitative urine PBG test (only if the quantitative urine PBG test is not available, persons who do not plan to perform the quantitative urine ALA test) (3) Persons who refuse to participate in this study

Design outcomes

Primary

Measure	Time frame
The PBG screening test with the Hoesch reagent will be compared to the PBG quantitative test, and the sensitivity and specificity will be calculated using the PBG quantitative test results as the gold standard. In addition, the positive concordance rate, negative concordance rate, false positive rate, and false negative rate of the Hoesch reagent will be evaluated to assess factors affecting test results.	—

Measure

Time frame

The PBG screening test with the Hoesch reagent will be compared to the PBG quantitative test, and the sensitivity and specificity will be calculated using the PBG quantitative test results as the gold standard. In addition, the positive concordance rate, negative concordance rate, false positive rate, and false negative rate of the Hoesch reagent will be evaluated to assess factors affecting test results.

—

Secondary

Measure	Time frame
Calculate the incidence of AHP and evaluate factors that influence the diagnosis of AHP.	—

Countries

Japan

Contacts

Public ContactMasaki Tago

Saga University Hospital Department of General Medicine

tagomas@cc.saga-u.ac.jp0952-31-6511

Outcome results