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
Completed · Phase 1, Phase 2 · NCT01506141
Conditions: Hunter Syndrome
At a glance
- Research payments reported, 2025
- $425,454
- U.S. investigators named
- 8
- Sites paid
- 8
- Planned or actual enrollment
- 15
About the trial
- Sponsor
- Takeda
- Tested
- Idursulfase-IT (drug), Elaprase (drug)
- Dates
- Started 2010-08-01; completion 2024-04-30
- Results posted
- Yes
This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV) Elaprase enzyme replacement therapy.
From ClinicalTrials.gov, last updated 2025-08-06. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Takeda Pharmaceuticals U.S.A., Inc. reported $425,454 in research payments for this study in 2025 (28 payments).
Products named: Elaprase
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Paul Harmatz, MD Pediatric Gastroenterology · Oakland, CA
- Monica Penon Portmann, MD Pediatrics · San Francisco, CA
- Barbara K. Burton, MD Medical Genetics · Chicago, IL
- Joseph Muenzer, MD Pediatrics · Chapel Hill, NC
- Damara Ortiz, M.D. Medical Genetics · Pittsburgh, PA
- Rizwan Hamid, MD, PHD Medical Genetics · Nashville, TN
- Susan E. Spiller, MD Pediatric Hematology & Oncology · Knoxville, TN
- David H. Viskochil, MD Medical Genetics · Salt Lake City, UT
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Vanderbilt University Medical Center, TN $145,123
- The University of North Carolina $136,329
- University of Utah Hospital and Clinics, UT $45,849
- University of Pittsburgh Physicians $42,820
- University of Michigan Health System, MI $20,226
- East Tennessee Childrens Hospital $18,021
- Ann & Robert H Lurie Childrens Hospital of Chicago, IL $14,663
- Seattle Children's Hospital, WA $2,424
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.