Extension Study of JR-051 for Patients with Fabry Disease
Phase 3
Completed
- Conditions
- Fabry disease
- Registration Number
- JPRN-jRCT2080223280
- Lead Sponsor
- JCR Pharmaceuticals Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 15
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
Individuals with severe pulmonary, hepatic, cardiac, or renal dysfunction (except for dysfunction associated with the progression of Fabry disease)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Adverse events<br>Laboratory tests<br>Antibody tests<br>Infusion associated reaction
- Secondary Outcome Measures
Name Time Method efficacy<br>GL-3 concentration in plasma<br>lyso-GL-3 concentration in plasma