Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06007417
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-11
First Post:
2023-08-09
Brief Title:
A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin GenSci004 in Treatment Naive Children With Growth Hormone Deficiency
Sponsor:
Changchun GeneScience Pharmaceutical Co Ltd
Organization:
Changchun GeneScience Pharmaceutical Co Ltd
Study Overview
Official Title:
The Efficacy and Safety of Once-weekly PEG-somatropin GenSci004 in Treatment-naive Children With Growth Hormone Deficiency A Randomized Open-label Parallel-group Active-Controlled Non-inferiority Phase 3 Study ELEVATE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
ELEVATE
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of weekly GenSci004 compared with daily Genotropin in treatment-naive children with growth failure due to GHD
Detailed Description:
The purpose of this Phase 3 study is to evaluate the efficacy safety and tolerability of weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve children with growth failure due to GHD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None