An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta)
NCT ID: NCT07344376
Last Updated: 2026-01-15
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
PHASE3
30 participants
INTERVENTIONAL
2018-05-23
2022-12-30
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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Hunterase
Single arm
Hunterase
0.5mg/kg weekly IV administration
Interventions
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Hunterase
0.5mg/kg weekly IV administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. (Subject who did not participate in the GC1111\_P3 study) Subject diagnosed with Hunter syndrome (MPS II) who received Hunterase for more than 6 months
3. (Subjects who did not participate in the GC1111\_P3 study) Males aged ≥ 5
4. Informed consent form voluntarily signed by the subject or by a legally acceptable representative
5. Subject who agrees to use contraception
Exclusion Criteria
2. Subject impossible to perform follow-up observation of the safety
3. Subject who received the treatment with another investigational product within 14 days prior to the start of study drug
4. Subject who plans to be treated with another investigational product during the study period
5. Subject who has history of tracheostomy, bone marrow transplant, or cord blood transplant
6. Any other inappropriate conditions for study participation at the investigator's discretion
MALE
No
Sponsors
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Samsung Medical Center, Sungkyunkwan University School of Medicine
UNKNOWN
GC Biopharma Corp
INDUSTRY
Responsible Party
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Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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GC1111_P3_Ex
Identifier Type: -
Identifier Source: org_study_id
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