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Enzyme Replacement Therapy

Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome

N/A
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

As the HGT-HIT-046 (NCT01506141) and SHP609-302 (NCT02412787) studies will be closed, this post-trial access (PTA) program provides TAK-609 to participants in these studies for whom the benefit:risk ratio of continued treatment with idursulfase-IT remains positive.

Eligible Conditions
  • Mucopolysaccharidosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,240 Previous Clinical Trials
4,147,677 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,290 Previous Clinical Trials
500,718 Total Patients Enrolled
~233 spots leftby Dec 2025
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