Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094
Completed · Phase 2, Phase 3 · NCT02412787
Conditions: Hunter Syndrome
At a glance
- Research payments reported, 2025
- $272,987
- U.S. investigators named
- 9
- Sites paid
- 9
- Planned or actual enrollment
- 56
About the trial
- Sponsor
- Shire
- Tested
- Idursulfase-IT (drug), Elaprase (drug)
- Dates
- Started 2015-04-14; completion 2024-04-18
- Results posted
- Yes
This extension study will allow participants that completed Study HGT-HIT-094 to continue receiving Elaprase treatment in conjunction with idursulfase IT or to continue receiving Elaprase treatment and begin concurrent IT treatment for those that did not receive idursulfase IT treatment in Study HGT-HIT-094.
From ClinicalTrials.gov, last updated 2025-06-19. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Takeda Pharmaceuticals U.S.A., Inc. reported $272,987 in research payments for this study in 2025 (10 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
- Jasmine L. Knoll, M.D. Medical Genetics · Phoenix, AZ
- Paul Harmatz, MD Pediatric Gastroenterology · Oakland, CA
- Barbara K. Burton, MD Medical Genetics · Chicago, IL
- Dorothy K. Grange, MD Medical Genetics · Saint Louis, MO
- Joseph Muenzer, MD Pediatrics · Chapel Hill, NC
- Devorah Segal, M.D., PH.D. Child Neurology · New York, NY
- Rabi Hanna, M.D Pediatric Hematology & Oncology · Cleveland, OH
- George A. Anadiotis, DO Ph.D. Medical Genetics · Portland, OR
- Damara Ortiz, M.D. Medical Genetics · Pittsburgh, PA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Unc Hospitals, NC $157,950
- Legacy Emanuel Medical Center, OR $32,771
- Washington University School of Medicine $31,863
- UCSF Langley Porter Psychiatric Hospital and Clinics, CA $28,359
- NYU Langone Hospitals, NY $6,838
- Ann & Robert H Lurie Childrens Hospital of Chicago, IL $5,322
- Phoenix Children's Hospital, AZ $4,500
- UPMC Children's Hospital of Pittsburgh, PA $3,038
- Cleveland Clinic, OH $2,346
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.