Status:
ACTIVE_NOT_RECRUITING
Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment
Lead Sponsor:
Takeda
Conditions:
Hunter Syndrome
Eligibility:
MALE
3-19 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
The drug being tested in this study is called idursulfase. Idursulfase is being tested for long term safety in participants with Hunter syndrome and cognitive impairment. The study will enroll up to ...
Eligibility Criteria
Inclusion
- The participant must have completed end of study assessments in studies HGT-HIT-046 \[NCT01506141\] or SHP609-302 \[NCT02412787\] and received a clinical benefit from idursulfase-IT in the opinion of the investigator.
- The participant, or participant's legally designated representative, must have been informed of the nature of this open-label extension and must have voluntarily signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form after all relevant aspects of the study have been explained and discussed. Written consent of the participant's legally designated representative (if applicable) and the participant's consent/assent, as relevant, must be obtained.
- The participant has continued to receive elaprase on a regular basis in studies HGT-HIT-046 or SHP609-302.
Exclusion
- The participant has experienced, in the opinion of the investigator, a safety or medical issue that contraindicates treatment with idursulfase-IT, including, but not limited to, uncontrolled seizure disorder, bleeding disorder, and clinically relevant hypertension.
- The participant has clinically relevant intracranial hypertension.
- The participant is enrolled in another clinical study, other than studies HGT-HIT-046 or SHP609-302, that involves clinical investigations or use of any investigational product (drug or \[intrathecal/spinal\] device) within 30 days prior to study enrolment or at any time during the study.
Key Trial Info
Start Date :
March 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2029
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06031259
Start Date
March 5 2024
End Date
January 1 2029
Last Update
November 6 2025
Active Locations (4)
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1
M.A.G.I.C. Clinic
Calgary, Alberta, Canada, T2E 7Z4
2
University of British Columbia
Vancouver, British Columbia, Canada, V6T1Z3
3
Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
4
Hopital Femme Mere Enfant
Bron, Auvergne-Rhône-Alpes, France, 02 69229