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

NCT05795361 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2026-04-13

No results posted yet for this study

Summary

As the HGT-HIT-046 (NCT01506141) and SHP609-302 (NCT02412787) studies are completed and 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.

Conditions

Interventions

DRUG

Idursulfase-IT

Participants will continue to receive the same dose of idursulfase-IT, once monthly, that was administered during the HGT-HIT-046 \[NCT01506141\] or SHP609-302 \[NCT02412787\] study \[10mg or 30mg\] along with intravenous (IV) infusions of standard-of-care therapy Elaprase via intrathecal drug delivery device (IDDD) or lumbar punctures.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States
  • Australia
  • Mexico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05795361 on ClinicalTrials.gov