Ignite Creation Date:
2024-05-06 @ 8:06 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02663024
Status:
UNKNOWN
Last Update Posted:
2016-01-26
First Post:
2016-01-17
Brief Title:
Study of Idursulfase-beta GC1111 in Hunter Syndrome
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
Phase 2 Randomized Double-blind Active-controlled Dose-ranging Study to Evaluate the Pharmacokinetics Pharmacodynamics and Safety of Idursulfase-beta GC1111 in Hunter Syndrome Mucopolysaccharidosis II Patients
Status:
UNKNOWN
Status Verified Date:
2016-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates the efficacy and safety of three doses of GC1111 in patients with Hunter Syndrome Participants will be randomized to one of three doses of GC1111 or comparator
Detailed Description:
This is a randomized double-blind active-controlled dose-ranging study where patient will receive one of the three doses of GC1111 05 mgkg 10 mgkg and 15 mgkg or ELAPRASE 05 mgkg Approximately 20 patients will be administrated each study drug once every week as an iv infusion for 24 weeks Efficacy of GC1111 will be evaluated in Six-Minute Walk Test 6MWT urine GlycosaminoglycansuGAG liver and spleen volume percent predicted Forced Vital CapacityFVC and cardiac size and function Also immunogenicity PharmacokineticsPK and safety will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None