NCT07344376

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

An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta) in Patients With Hunter Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: GC Biopharma Corp · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• MPS II
• Hunter Syndrome (MPS II)
• Hunter Syndrome
• Hunterase
• GC1111

Interventions

Type	Name	Description
DRUG	Hunterase	0.5mg/kg weekly IV administration

Timeline

• Start date: 2018-05-23
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: South Korea