An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

August 1, 2010

Primary Completion Date

April 30, 2024

Study Completion Date

April 30, 2024

Conditions
Hunter Syndrome
Interventions
DRUG

Idursulfase-IT

Idursulfase-IT once monthly via IDDD.

DRUG

Elaprase

Weekly IV infusions of commercially available Elaprase.

Trial Locations (9)

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

27599

University of North Carolina at Chapel Hill, Chapel Hill

60611

Ann & Robert H Lurie Childrens Hospital of Chicago, Chicago

84132

University of Utah Hospital, Salt Lake City

97227

Legacy Emanuel Hospital, Portland

98105

Seattle Children's Hospital, Seattle

37232-9559

Vanderbilt Children's Hospital, Nashville

Unknown

British Columbia Children's Hospital, Vancouver

B46NH

Birmingham Children's Hospital, Birmingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY