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NCT05594992

An Extension Study of JR-141 to Evaluate the Long-term Safety and Efficacy in MPS II (Hunter Syndrome) Subjects

Enrolling by Invitation
PHASE3All AgesInterventionalTreatment
JCR Pharmaceuticals Co., Ltd.
~80 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:JR-141

At a glance

Recruiting sites
0 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in heparan sulfate concentrations in cerebrospinal fluid from each subject's first administration of JR-141 throughout the Parent Study (JR-141-GS31) or this study to each time point
Measured over [A-1, A-2, A-3: Week 157, 209, 261] [A-4: Week 131, 183, 235, 287]
+3 more outcomes measured

Conditions

Mucopolysaccharidosis II

Explore related trials

Hunter Syndrome

Where it's being run

10 sites across 9 states
Brazil2
California1
Pennsylvania1
Argentina1
France1
Germany1
Italy1
Poland1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Change in heparan sulfate concentrations in cerebrospinal fluid from each subject's first administration of JR-141 throughout the Parent Study (JR-141-GS31) or this study to each time point[A-1, A-2, A-3: Week 157, 209, 261] [A-4: Week 131, 183, 235, 287]

    Assessment will be mandatory for the first two years after starting JR-141 administration through the parent study or the extension study.

  • Change in neurocognitive testing, calculated by the BSID-III or KABC-II, from each subject's first administration of JR-141 throughout the Parent Study (JR-141-GS31) or this study[A-1: Week 157, 209, 261] [A-2: Week 131, 157, 183, 209, 261] [A-3: Week 131, 157, 209, 261 ] [A-4: Week 131, 157, 183, 235, 287]
  • Change in neurocognitive testing, calculated by the VABS-II from each subject's first administration of JR-141 throughout the Parent Study (JR-141-GS31) or this study[A-1: Week 157, 209, 261] [A-2: Week 131, 157, 183, 209, 261] [A-3: Week 131, 157, 209, 261 ] [A-4: Week 131, 157, 183, 235, 287][B-1: Week 78, 105, 157, 209, 261] [B-2: Week 78, 105, 131, 157, 209, 261]
  • Change in neurocognitive testing, calculated by the Wechsler, from each subject's first administration of JR-141 throughout the Parent Study (JR-141-GS31) or this study[B-1: Week 78, 105, 157, 209, 261] [B-2: Week 78, 105, 131, 157, 209, 261]