clinical trial · NCT02412787
Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094
Shire·phase3·completed·n = 56
Hunter SyndromeIdursulfase-ITElaprase
brief summary
This extension study will allow participants that completed Study HGT-HIT-094 to continue receiving Elaprase treatment in conjunction with idursulfase IT or to continue receiving Elaprase treatment and begin concurrent IT treatment for those that did not receive idursulfase IT treatment in Study HGT-HIT-094.
started
Apr 14, 2015
primary completion
Apr 18, 2024
completion
Apr 18, 2024
last updated
Jun 19, 2025
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol