Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542809
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Evaluation of the Propensity of Patients Under rhGH to Envision a Modification of Their Treatment Regimen Toward LAGH
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Propensity of Patients Under rhGH to Envision a Modification of Their Treatment Regimen Toward LAGH
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOWARD-LAGH
Brief Summary:
Daily subcutaneous injections of rhGH can be burdensome for patients leading to poor adherence and reduced growth outcomes This has spurred the development of long-acting GH LAGH analogues that allow for weekly biweekly or monthly injections Previous studies on LAGH analogues have demonstrated their non-inferiority compared to daily rhGH in terms of increasing growth velocity and improving body composition in children and adults with growth hormone deficiency GHD respectively without significant and unexpected adverse events Since 2020 three molecules have received approval from the Food and Drug Administration FDA for the treatment of pediatric GHD lonapegsomatropin somatrogon and somapacitan These LAGH analogues may offer better patient acceptance improved tolerance and greater therapeutic flexibility However these LAGH analogues could also be associated with potential clinical issues in terms of therapeutic monitoring incidence and duration of side effects and long-term safety due to a non-physiological GH profile The introduction of these new LAGH products will require clinicians to identify optimal candidates for LAGH therapy and gain knowledge on monitoring and adjusting treatment
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