drugset / Trial / NCT05795361

Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome

NCT05795361

Expanded access Available Takeda

Summary

As the HGT-HIT-046 (NCT01506141) and SHP609-302 (NCT02412787) studies are completed and closed, this post-trial access (PTA) program provides TAK-609 to participants in these studies for whom the benefit:risk ratio of continued treatment with idursulfase-IT remains positive.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Background idursulfase Protein / enzyme biologic 10 mg Intrathecal
Background idursulfase Protein / enzyme biologic 30 mg Intrathecal