Summary

Eligibility
for males (full criteria)
Location
at Oakland, California and other locations
Dates
study started

Description

Summary

This post-trial access program is to allow continued access for people who participated and are benefitting from treatment on the HGT-HIT-046 (NCT01506141) or SHP609-302 (NCT02412787) studies, which will be closed down. Idursulfase-IT also known as TAK-609, is a medicine to help treat Hunter Syndrome and issues with remembering, learning new things, and concentrating, also called cognitive impairment.

Official Title

Post-trial Access Program: Idursulfase-IT (HGT-2310) in Conjunction With Intravenous Elaprase in Pediatric Patients With Hunter Syndrome and Cognitive Impairment

Keywords

Hunter Syndrome, Mucopolysaccharidosis II, Syndrome, Idursulfase-IT

Eligibility

You can join if…

Open to males

  1. Participants will have completed the treatment period of the HGT-HIT-046 (NCT01506141) or SHP609-302 (NCT02412787) study prior to the first dose on this program.
  2. Participant and/or a parent(s)/legal guardian is informed of the nature of this compassionate post-trial access program and can provide written informed consent for themselves or the child to participate (with assent from the child when appropriate prior to treatment).

You CAN'T join if...

  1. Participant has a condition that in the opinion of the treating physician may compromise their safety.
  2. Participant has a known hypersensitivity to idursulfase-IT or its components.

Locations

  • The Regents of the University of California not accepting new patients
    Oakland California 94609 United States
  • Childrens Hospital Orange County not accepting new patients
    Anaheim California 92868 United States

Details

Status
not accepting new patients
Start Date
Sponsor
Takeda
ID
NCT05795361
Study Type
Expanded Access
Last Updated