Clinical trial
Post-trial Access Program: Idursulfase-IT (HGT-2310) in Conjunction With Intravenous Elaprase® in Pediatric and Adult Patients With Hunter Syndrome and Cognitive Impairment
Name
TAK-609-5005
Description
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.
Trial arms
Treatment
Idursulfase-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.
Other names:
HGT-2310, TAK-609
Size
-1
Eligibility criteria
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.
Protocol
{'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}}
Updated at
2024-04-04
1 organization
1 product
1 indication
Organization
TakedaProduct
Idursulfase-ITIndication
Mucopolysaccharidosis II (MPS II)