drugset
drugset / Trial / NCT06031259

Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment

NCT06031259 ↗

Phase 2/3 Active not recruiting 6 enrolled Takeda
NaSingle-groupOpen-labelTreatment

Summary

The study is an extension of two previous studies (HGT-HIT-046 \[NCT01506141\] and SHP609-302 \[NCT02412787\]). Participants must have completed one of the previous studies. The main aim of this study is to collect more information about the safety of the treatments, idursulfase-IT and elaprase, in children and adults with Hunter syndrome and cognitive impairment. Participants will receive the same treatment as in the previous studies.

Timeline

Start
2024-03-05
Primary completion
2029-01-01
Completion
2029-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject idursulfase Protein / enzyme biologic — Intrathecal
Subject idursulfase Protein / enzyme biologic — Intravenous

Indications

No indication recorded.