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

Takeda

Status

Conditions: Hunter Syndrome

Treatments: Drug: Idursulfase-IT

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT05795361

TAK-609-5005

Details and patient eligibility

About

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.

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

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).

Exclusion criteria

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.