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ACTIVE NOT RECRUITING
NCT06031259
PHASE2/PHASE3

Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment

Sponsor: Takeda

View on ClinicalTrials.gov

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

DRUG

Idursulfase-IT

Idursulfase-IT intrathecally via IDDD.

DRUG

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