AVAILABLENot Applicable

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

United States

Plain-language 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.

Who can participate

SexMALE

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Inclusion criteria

✓. 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.
✓. 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).

Exclusion criteria

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

Trial details

NCT IDNCT05795361

SponsorTakeda

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

Contact for this trial

Takeda Contact

+1877-825-3327 medinfoUS@takeda.com

View on ClinicalTrials.gov More Hunter Syndrome trials