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Clinical Trial Summary

The study is an extension of two previous studies (HGT-HIT-046 [NCT01506141] and SHP609-302 [NCT02412787]). Participants must have completed one of the previous studies. The main aim of this study is to collect more information about the safety of the treatments, idursulfase-IT and elaprase, in children and adults with Hunter syndrome and cognitive impairment. Participants will receive the same treatment as in the previous studies.


Clinical Trial Description

The drug being tested in this study is called idursulfase. Idursulfase is being tested for long term safety in participants with Hunter syndrome and cognitive impairment. The study will enroll up to approximately 8 patients. Participants will receive idursulfase-IT via intrathecal drug delivery device (IDDD) once monthly along with elaprase intravenous (IV) infusion, weekly. This multi-center trial will be conducted in France and Canada. The overall time to participate in this study is approximately 10.4 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06031259
Study type Interventional
Source Takeda
Contact Takeda Contact
Phone +1-877-825-3327
Email medinfoUS@takeda.com
Status Recruiting
Phase Phase 2/Phase 3
Start date March 5, 2024
Completion date June 1, 2034

See also
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Completed NCT03292887 - Hunter Outcome Survey (HOS)
Active, not recruiting NCT02455622 - Long-term Evaluation on Height and Weight in Patients With MPS II Who Started Treatment at < 6 Years of Age Phase 4
Completed NCT00882921 - An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients
Completed NCT00920647 - 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® Phase 1/Phase 2
Completed NCT01449240 - Collection and Study of Cerebrospinal Fluid in Patients With Hunter Syndrome
Completed NCT03920540 - A Study of GC1111 in Hunter Syndrom Patients Phase 3
Completed NCT02055118 - Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment Phase 2/Phase 3
Completed NCT01645189 - Safety and Efficacy of Hunterase Phase 3
Completed NCT00937794 - Screening Study to Identify Pediatric Patients With Hunter Syndrome Who Demonstrate Evidence of Central Nervous System (CNS) Involvement and Who Are Currently Receiving Treatment With Elaprase®
Recruiting NCT02171104 - MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis Phase 2
Recruiting NCT02044692 - The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients N/A
Completed NCT03582449 - Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)
Completed NCT01822184 - Observational Study to Evaluate Neurodevelopmental Status in Pediatric Patients With Hunter Syndrome (MPS II)
Recruiting NCT05494593 - A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II) Phase 4
Completed NCT00607386 - Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy Phase 4
Completed NCT01043640 - Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders Phase 2
Terminated NCT01330277 - Biomarkers for Hunter Syndrome
Completed NCT01506141 - 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 Phase 1/Phase 2