NCT05058391

A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India

A Prospective, Multicenter, Single-arm, Open-label, Interventional Phase IV Study to Evaluate the Safety and Efficacy of Idursulfase (r-DNA Origin) (Elaprase™) in Indian Pediatric and Adult Population With Hunter Syndrome (Mucopolysaccharidosis II)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to learn more about the safety profile of Elaprase in Indian children and adults with hunter syndrome. Participants will receive Elaprase once per week over a 3-hour period which can be reduced to 1 hour as determined by the study doctor. Participants will need to visit the clinic weekly during the duration of the study.

Conditions

• Hunter Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Elaprase	Elaprase IV infusion.

Timeline

• Start date: 2022-04-21
• Primary completion: 2024-04-06
• Completion: 2024-04-18
• First posted: 2021-09-27
• Last updated: 2025-01-23
• Results posted: 2025-01-23

Locations

5 sites across 1 country: India