drugset / Trial / NCT05795361
Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome
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
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | idursulfase | Protein / enzyme biologic | 10 mg | Intrathecal |
| Background | idursulfase | Protein / enzyme biologic | 30 mg | Intrathecal |