A Phase III Study of FYU-981 in Hyperuricemic Pediatric Patients with or without Gout (Extension Study)

A Study to Evaluate the Safety and Efficacy of FYU-981 in Hyperuricemic Pediatric Patients with or without Gout (Phase III Study) (Extension Study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041220061

Enrollment

Registered

2022-08-31

Start date

2023-01-12

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

Hyperuricemic pediatric patients with or without gout

Interventions

FYU-981 is administered orally once daily with the maintenance doses of 0.5 to 4 mg/day.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Hyperuricemic pediatric patients with or without gout, who completed the observation for 30 weeks of Study FYU-981-018 (jRCT2031220036).

Exclusion criteria

Exclusion criteria: -Kidney calculi or clinically significant urinary calculi -Patients deemed inappropriate by the investigator to conduct this study etc.

Design outcomes

Primary

Measure	Time frame
Percentage of subjects with serum urate <=6.0 mg/dL at the end of administration	—

Contacts

Public ContactDevelopment Department

FUJI YAKUHIN CO., LTD.

clinical-trials@fujiyakuhin.co.jp+81-48-644-3403

Outcome results

None listed

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