An Open Label Extension of Study HGT-HIT-094 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Idursulfase Administered in Conjunction With Elaprase in Patients With Hunter Syndrome and Cognitive Impairment
Phase of Trial: Phase II/III
Latest Information Update: 03 Jan 2018
At a glance
- Drugs Idursulfase (Primary)
- Indications Cognition disorders; Mucopolysaccharidosis II
- Focus Adverse reactions
- Sponsors Shire
- 21 Nov 2016 Time frame of primary endpoint has changed from week 148 to month 60.
- 21 Nov 2016 Planned number of patients changed from 54 to 49.
- 21 Nov 2016 Planned End Date changed from 1 Jun 2019 to 1 Sep 2022.