Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01506141 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Hunter Syndrome, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 9
- Study locations
NCT01506141: Completed Phase 1 study of Hunter Syndrome, sponsored by Takeda.
NCT01506141 is a Phase 1 study of Hunter Syndrome that has completed, run by Takeda. The registered enrollment target is 15 participants, below the 353-participant average among 5 other Hunter Syndrome trials with a reported enrollment target (96% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01506141, a Phase 1 study of Hunter Syndrome, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 9
- Study locations
Study Summary
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.
Primary Outcome
An adverse event (AE) is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, and/or laboratory changes occurring in any phase of a clinical trial, and whether or not considered study drug-related. TEAEs were defined as all AEs occurring on or after the first IDDD surgery date or first dose (whichever is earlier) for the participant (whether it is in this extension study or in HGT HIT-045 \[NCT00920647\]) and be
Conditions Studied
Interventions
- DRUG Idursulfase-IT
- DRUG Elaprase
Study Locations (9)
Illinois
- Ann & Robert H Lurie Childrens Hospital of Chicago - Chicago
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Oregon
- Legacy Emanuel Hospital - Portland
Pennsylvania
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Tennessee
- Vanderbilt Children's Hospital - Nashville
Utah
- University of Utah Hospital - Salt Lake City
Washington
- Seattle Children's Hospital - Seattle
British Columbia
- British Columbia Children's Hospital - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-08-01 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 1 |
What the finished NCT01506141 record still lists
NCT01506141 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 353-participant average among 5 other Hunter Syndrome trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Hunter Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Idursulfase-IT is the first listed.
NCT01506141 lists 9 locations in 9 states (Illinois, North Carolina, Oregon).
Frequently Asked Questions
What is clinical trial NCT01506141 about?
NCT01506141 is a clinical study titled "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". 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.
What is the current status of trial NCT01506141?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2010-08-01. Estimated completion is 2024-04-30.
What conditions does trial NCT01506141 study?
This clinical trial studies the following conditions: Hunter Syndrome.
What interventions are being tested in trial NCT01506141?
The interventions under investigation include: Idursulfase-IT (DRUG), Elaprase (DRUG).
Who is sponsoring clinical trial NCT01506141?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01506141 being conducted?
This trial has 9 study locations across Illinois, North Carolina, Oregon, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hunter Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
COMPLETED · Phase 1
-
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
ACTIVE NOT RECRUITING · Phase 2
-
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
COMPLETED · Phase 2
-
Hunter Outcome Survey (HOS)
COMPLETED
-
Observational Study to Evaluate Neurodevelopmental Status in Pediatric Patients With Hunter Syndrome (MPS II)
COMPLETED
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01889381 · 15 participants · Phase 2
Human Craniomaxillofacial Allotransplantation
- NCT02530073 · 15 participants · NA
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
- NCT02535936 · 15 participants · NA
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
- NCT02918474 · 15 participants · NA
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI