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

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

Timeline

Start

2018-05-23

Primary completion

2022-12-30

Completion

2022-12-30

Publications

• Im M, Song A, Park H, Kim J, Kim C, Noh ES, Bae GY, Sung J, Hwang J, Ahn YJ, Kim H, Oh Y, Kim B, Cho SY. Sustained clinical benefit of idursulfase beta in mucopolysaccharidosis II: two-year experience from a phase 3 extension study including patients switched from idursulfase. Orphanet J Rare Dis. 2026 Jul 9. doi: 10.1186/s13023-026-04492-2. Online ahead of print.

Drugs

Indications