A Study of JR-141 in Patients With Mucopolysaccharidosis II
NCT ID: NCT03568175
Last Updated: 2022-11-14
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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COMPLETED
PHASE2/PHASE3
28 participants
INTERVENTIONAL
2018-08-01
2020-02-20
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 2.0 mg/kg/week
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. In the case of a patient who is under the age of 20 years or from whom it is not possible to obtain consent due to intellectual disabilities associated with MPS II, he may be included if written consent can be provided by legal representative (however, written consent should be obtained from the patient himself too, whenever possible)
3. Males with confirmed diagnosis of MPS II, based on deficient activity of iduronate-2-sulfatase (IDS) in leucocytes, plasma or fibroblasts and/or pathogenic mutations identified in the IDS gene, etc.
4. Naïve patients or patients who are receiving stable enzyme replacement therapy with Elaprase for more than 8 weeks before the observational period starts.
Exclusion Criteria
2. Judged by the investigator or subinvestigator as being unable to undergo lumbar puncture, including those who have difficulties in taking position for lumbar puncture due to joint contracture or those who are likely experience difficulty breathing during the lumbar puncture process.
3. Judged by the investigator or subinvestigator to be ineligible to participate in the study due to a history of serious drug allergy or sensitivity.
4. Patients who have received other investigational product within 4 months before enrollment in the study.
5. Otherwise judged by the investigator or subinvestigator to be ineligible to participate in the study.
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
Hokkaido Clinical site
Hokkaido, , Japan
Kanagawa Clinical 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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Related Links
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A Phase 2/3 Trial of Pabinafusp Alfa, IDS Fused with Anti-Human Transferrin Receptor Antibody, Targeting Neurodegeneration in MPS-II
Other Identifiers
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JR-141-301
Identifier Type: -
Identifier Source: org_study_id
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