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drugset / Trial / NCT03359213

A Study of JR-141 in Patients With Mucopolysaccharidosis II (BR21)

NCT03359213 ↗

Phase 2 Completed 18 enrolled JCR Pharmaceuticals Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

A Phase II open-label, randomized, parallel group, 2 sites (Brazil), designed to evaluate the safety and efficacy of 3 doses of study drug for the treatment of the MPS II.

Timeline

Start
2018-07-26
Primary completion
2019-10-04
Completion
2019-10-04

Drugs

EvaluationDrugModalityDoseRoute
Subject PABINAFUSP ALFA Protein / enzyme biologic 1 mg/kg Intravenous
Subject PABINAFUSP ALFA Protein / enzyme biologic 2 mg/kg Intravenous
Subject PABINAFUSP ALFA Protein / enzyme biologic 4 mg/kg Intravenous

Indications

mucopolysaccharidosis type 2