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Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment
Sponsor: Takeda
Summary
The study is an extension of two previous studies (HGT-HIT-046 \[NCT01506141\] and SHP609-302 \[NCT02412787\]). Participants must have completed one of the previous studies. The main aim of this study is to collect more information about the safety of the treatments, idursulfase-IT and elaprase, in children and adults with Hunter syndrome and cognitive impairment. Participants will receive the same treatment as in the previous studies.
Official title: 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
Key Details
Gender
MALE
Age Range
3 Years - 19 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2024-03-05
Completion Date
2029-01-01
Last Updated
2025-11-06
Healthy Volunteers
No
Conditions
Interventions
Idursulfase-IT
Idursulfase-IT intrathecally via IDDD.
Elaprase
Elaprase IV infusion.
Locations (4)
M.A.G.I.C. Clinic
Calgary, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Hopital Femme Mere Enfant
Bron, Auvergne-Rhône-Alpes, France