Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06103513
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-10-17
Brief Title:
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
A Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children With Growth Hormone Deficiency in the First Year of Treatment
Status:
RECRUITING
Status Verified Date:
2023-10
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:
A prospective randomized open-label single-blinded study of 50 subjects with growth hormone deficiency ages 5 to 15 years in which 25 subjects will initiate rhGH therapy at 03mgkgweek and the remaining 25 subjects will initiate their rhGH treatment at 02 mgkgweek for the first 12 months of treatment Safety parameters height velocity and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy
Detailed Description:
Investigators propose a prospective randomized open-label single-blinded study of 50 subjects with growth hormone deficiency ages 5 to 15 years 25 subjects will be randomized to initiate a dose of 03 mgkgweek 028-032 mgkgweek and the remaining 25 subjects will initiate their rhGH treatment at 02 mgkgweek 018-022 mgkgweek for the first 12 months of treatment Safety parameters height velocity and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy
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