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

Recruiting at27 trial locations

Age: Any Age

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Takeda

No Placebo Group

Trial Summary

What is the purpose of this 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.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

Inclusion Criteria

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.

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).

Treatment Details

Interventions

• Elaprase (Enzyme Replacement Therapy)
• Idursulfase-IT (Enzyme Replacement Therapy)

Elaprase is already approved in Canada for the following indications:

Approved in Canada as Elaprase for:

• Hunter syndrome (Mucopolysaccharidosis II, MPS II)

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier