Hunter Syndrome
Conditions
Brief summary
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.
Interventions
DRUGIdursulfase-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
Takeda
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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.
Countries
Australia, Mexico, Spain, United Kingdom, United States
Contacts
Primary ContactTakeda Contact
Outcome results
None listed