clinical trial · NCT01506141
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
Takeda·phase2·completed·n = 15
Hunter SyndromeIdursulfase-ITElaprase
brief summary
This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV) Elaprase enzyme replacement therapy.
started
Aug 1, 2010
primary completion
Apr 30, 2024
completion
Apr 30, 2024
last updated
Aug 6, 2025
official title
An Open-Label Extension of Study HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Intrathecal Idursulfase-IT Administered in Conjunction With Intravenous Elaprase® in Pediatric Patients With Hunter Syndrome and Cognitive Impairment
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol