Ignite Creation Date:
2024-05-06 @ 12:44 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01645189
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2012-07-16
Brief Title:
Safety and Efficacy of Hunterase
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
To Evaluate the Safety and Efficacy of HunteraseIdursulfase-beta in Hunter Syndrome Patients 6 Years of Age Receiving Idursulfase Enzyme Replacement Therapy
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
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:
GC1111
Brief Summary:
The objective of this study is to determine the safety and efficacy of once weekly dosing of idursulfase-beta 05mgkg administered by intravenousIV infusion for Hunter syndrome patients 6 years old
Detailed Description:
None
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