An Extension Study of JR-141 in Patients With Mucopolysaccharidosis Type II
NCT ID: NCT04348136
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
27 participants
INTERVENTIONAL
2019-09-01
2030-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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JR-141
JR-141
IV infusion, 2.0 mg/kg/week
Interventions
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JR-141
IV infusion, 2.0 mg/kg/week
Eligibility Criteria
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Inclusion Criteria
2. A patient capable of providing written informed consent in person (However, this is not required for patients aged younger than 20 years at the time of consent or patients with intellectual disability associated with MPS II whose willingness cannot be verified.)
3. For patients aged younger than 20 years at the time of consent or patients with intellectual disability associated with MPS II whose willingness cannot be verified, written consent must be obtained from the legally acceptable representative. (Wherever possible, written consent of the patient should be obtained.)
4. Male patient whose partner is of child-bearing potential and agrees to use a medically accepted, highly effective method of contraception.
Exclusion Criteria
2. A patient with a history of serious drug allergy or hypersensitivity that precludes participation in this study in the opinion of the investigator or subinvestigator.
3. A patient judged to be ineligible by the investigator or subinvestigator for other reasons.
MALE
No
Sponsors
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JCR Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fukui Clinical site
Fukui, , Japan
Fukuoka Clinical site 2
Fukuoka, , Japan
Fukuoka Clinical site
Fukuoka, , Japan
Gifu Clinical site
Gifu, , Japan
Hiroshima Prefectural Hospital
Hiroshima, , Japan
Hokkaido Clinical site
Hokkaido, , Japan
Kananagawa Ckinical site
Kanagawa, , Japan
Kumamoto Clinical site
Kumamoto, , Japan
Okayama Clinical site
Okayama, , Japan
Okayama Clinical site 2
Okayama, , Japan
Okinawa Clinical site
Okinawa, , Japan
Osaka Clinical site 3
Osaka, , Japan
Osaka Clinical site 2
Osaka, , Japan
Osaka Clinical site
Osaka, , Japan
Saitama Clinical site
Saitama, , Japan
Shizuoka Clinical site
Shizuoka, , Japan
Shizuoka Clinical site 2
Shizuoka, , Japan
Tochigi Clinical site
Tochigi, , Japan
Tokyo Clinical site
Tokyo, , Japan
Tottori Clinical site
Tottori, , Japan
Countries
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Other Identifiers
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JR-141-302
Identifier Type: -
Identifier Source: org_study_id
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