Extension Study of JR-051 for Patients with Fabry Disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223280

Enrollment

Registered

2016-08-02

Start date

2016-07-01

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 : Agalsidase Beta (Genetical Recombination) [Agalsidase Beta Biosimilar 1] INN of investigational material : agalsidase beta Therapeutic category code : 39

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who have participated in the previous study ("Evaluation Study to Pharmacodynamic Effects of JR-051 for Patients with Fabry Disease (Protocol number: JR-051-301)" and have completed the 52-week study visit, but for whom the principal investigator or the subinvestigator judges that there is no concern about shifting to the extension study in terms of the safety.

Exclusion criteria

Exclusion criteria: Individuals with severe pulmonary, hepatic, cardiac, or renal dysfunction (except for dysfunction associated with the progression of Fabry disease)

Design outcomes

Primary

Measure	Time frame
safety Adverse events Laboratory tests Antibody tests Infusion associated reaction	—

Secondary

Measure	Time frame
efficacy GL-3 concentration in plasma lyso-GL-3 concentration in plasma	—

Countries

Japan

Outcome results

None listed

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