Trials / Available
AvailableNCT05795361
Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome
Post-trial Access Program: Idursulfase-IT (HGT-2310) in Conjunction With Intravenous Elaprase® in Pediatric and Adult Patients With Hunter Syndrome and Cognitive Impairment
- Status
- Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Takeda · Industry
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
Timeline
- First posted
- 2023-04-03
- Last updated
- 2026-04-13
Locations
22 sites across 5 countries: United States, Australia, Mexico, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT05795361. Inclusion in this directory is not an endorsement.