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

Takeda

Overview

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.

Study Type

EXPANDED_ACCESS

Conditions

Hunter Syndrome

Interventions

Idursulfase-ITDRUG

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.

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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.

Locations (22)

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Central Contacts

Takeda Contact

CONTACT

+1877-825-3327 medinfoUS@takeda.com

Data from ClinicalTrials.gov

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