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NCT03920540 Clinical Trial

A Study of GC1111 in Hunter Syndrom Patients

Hunter Syndrome Clinical Trial

Official title:
Phase 3, Double-blind, Randomized, Active-controlled (Part 1) and Open-labeled, Historical Placebo Controlled (Part 2) Study to Evaluate the Efficacy of Hunterase (Idursulfase-beta) in Hunter Syndrome (Mucopolysaccharidosis II) Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03920540
Other study ID # GC1111_P3
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 9, 2017
Est. completion date February 15, 2022

Study information
Verified date April 2024
Source GC Biopharma Corp
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date February 15, 2022
Est. primary completion date February 15, 2022
Accepts healthy volunteers No
Gender Male
Age group 5 Years and older
Eligibility Inclusion Criteria: - Patients diagnosed with Hunter syndrome - Male at the age of = 5 - Adequate abilities (including 6-MWT) to participate in this study in the opinion of the investigator. - Voluntarily signed written informed consent to participation in this study - Consent to contraception Exclusion Criteria: - Prior treatment with iduronate-2-sulfatase ERT - History of bronchotomy, bone marrow trasplanation, or cord blood transplanation. - Known hypersensitivity reactions to any of the components of the invetigational product - Prior or planned administration of other investigational products within 30 days before treatment with the investigational product in this study or duirng this study. - Unable to perform 6-MWT. - Female

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• GC1111
GC1111 is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
• Comparator
Comparator is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.

Locations
Country Name City State
Korea, Republic of Samsug Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in 6-MWT at Week 53 from baseline
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 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
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 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