TAK-609-5005
Recruiting
Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome
Clinicaltrials.gov
#NCT05795361About this clinical trial
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.
US
GB
MX
2+
Expanded Access clinical trial.
At a glance
What medical conditions are being studied?
Hunter Syndrome
What is the clinical trial testing?
Idursulfase-IT
Are placebos part of the clinical trial?
No
How long is participation in the clinical trial?
Each participant will be in the program as long as there is a benefit in the treatment, or an appropriate alternative treatment becomes available, or the participant chooses to discontinue treatment
Key requirements
Sexes
Male
Age
All
Healthy volunteers?
No
Entry criteria
Must have completed treatment in study HGT-HIT-046 (NCT01506141) or SHP609-302 (NCT02412787)
Additional entry criteria will be discussed with the study doctor.
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