Trial Profile

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: Active, no longer recruiting

Phase of Trial: Phase II/III

Latest Information Update: 30 Apr 2025

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At a glance

23 Apr 2025 Timeframe for primary endpoints changed from 10.4 years to 4.8 years.
23 Apr 2025 Planned End Date changed from 1 Jun 2034 to 1 Jan 2029.
23 Apr 2025 Planned primary completion date changed from 1 Jan 2034 to 1 Jan 2029.

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