Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513171
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2020-08-07
Brief Title:
Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children
Sponsor:
Xiamen Amoytop Biotech Co Ltd
Organization:
Xiamen Amoytop Biotech Co Ltd
Study Overview
Official Title:
A Multi-center Randomized Positive-control Phase 23 Combined Study of Y-shape Pegylated Somatropin in Prepubertal Children With Growth Hormone Deficiency
Status:
COMPLETED
Status Verified Date:
2024-01
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:
None
Brief Summary:
This is a multicenter randomized open-labeled positive controlled phase 23 combined study to evaluate the safety and efficacy of weekly Y-shape pegylated somatropin compared to daily somatropin Norditropin in prepubertal treatment-naive children with growth hormone deficiency
Detailed Description:
This multicenter randomized open-labeled positive controlled study is divided into two stages The first one is aimed to exploit the optimal dose of Y-shape pegylated somatropin while the second one is aimed to confirm the efficacy and safety of the study drug A total of 400 prepubertal children with growth hormone deficiency were expected to enrolled Subjects will firstly undergo a 52 weeks treatment and then followed for 5 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None