Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05422482` - A Study to Evaluate the Safety, Tolerability, PK and PD of Intracerebroventricular GC1123 in Patients With MPS Ⅱ	Phase 1
Completed	`NCT00630747` - Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase	Phase 2/Phase 3
Completed	`NCT03292887` - Hunter Outcome Survey (HOS)
Active, not recruiting	`NCT02412787` - Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094	Phase 2/Phase 3
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
Recruiting	`NCT06031259` - Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment	Phase 2/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	`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

NCT number	NCT03582449
Study type	Observational
Source	Takeda
Contact
Status	Completed
Phase
Start date	January 19, 2018
Completion date	May 10, 2020

Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms