An Open-Label Extension for Subjects in Studies HGT-HIT-046 and SHP609-302 Evaluating Long-Term Safety of Intrathecal Idursulfase-IT Administered in Conjunction with Intravenous Elaprase® in Subjects with Hunter Syndrome and Cognitive Impairment

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504127-90-00

Acronym

TAK-609-3001

Enrollment

Registered

2024-02-13

Start date

2024-04-08

Completion date

Unknown

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hunter Syndrome and Cognitive Impairment

Brief summary

01. The primary endpoint of this study is the safety of intrathecal idursulfase-IT administration. Safety will be assessed by AEs (by type, severity, and relationship to treatment [idursulfase-IT, the IDDD, device surgical procedure, or IT administration process] and IV Elaprase infusion).

Interventions

DRUGIdursulfase (idursulfase-IT [HGT-2310])

Eligibility

Sex/Gender

Male

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
01. The primary endpoint of this study is the safety of intrathecal idursulfase-IT administration. Safety will be assessed by AEs (by type, severity, and relationship to treatment [idursulfase-IT, the IDDD, device surgical procedure, or IT administration process] and IV Elaprase infusion).	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026