Clinical Trial

An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta)

Name: An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta) — clinical trial record (NCT07344376)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Completed Phase 3

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Summary

The objective of this study is to assess the long-term safety and efficacy of Hunterase for approximately 1 year in subjects who completed the end of study (EOS) visit (Visit 54) tests in the Phase 3 Hunterase study and patients who received Hunterase for more than 6 months

Trial Details

NCT Number	NCT07344376
Lead Sponsor	GC Biopharma Corp Collaborators: Samsung Medical Center
Conditions	MPS II, Hunter Syndrome (MPS II), Hunter Syndrome, Hunterase, GC1111
Enrollment	30 participants
Start Date	2018-05-23
Primary Completion	2022-12-30 (estimated)
Study Completion	2022-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-15