An multicenter open-label long-term continuous administration study to investigate the safety and tolerability of lucerastat in Japanese Fabry disease patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224890

Enrollment

Registered

2019-09-27

Start date

2019-10-01

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

Fabry disease

Interventions

investigational material(s) Generic name etc : Lucerastat (ACT-434964) INN of investigational material : lucerastat Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Admin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who complete the preceding study and continue its eligibility

Exclusion criteria

Exclusion criteria: Patients with a risk of worsening of clinical symptoms due to an organ lesion during the study period at the discretion of the investigator

Design outcomes

Primary

Measure	Time frame
safety TEAEs and SAEs	—

Secondary

Measure	Time frame
efficacy change of biomarkers	—

Countries

Japan

Contacts

Public ContactYoshinari Yokoyama

Nxera Pharma Japan ltd

JP-MB-chiken.info@nxera.life+81-3-5962-5600

Outcome results

None listed

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