Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06129539
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2023-11-08
Brief Title:
A Study to Assess the Efficacy Safety and Pharmacokinetics of Debio 4326 in Pediatric Participants Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty
Sponsor:
Debiopharm International SA
Organization:
Debiopharm International SA
Study Overview
Official Title:
An Open-Label Single-Arm Multi-Center Phase 3 Study on the Efficacy Safety and Pharmacokinetics of Debio 4326 a Triptorelin 12-month Formulation in Pediatric Participants Who Are Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty
Status:
RECRUITING
Status Verified Date:
2024-09
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:
LIBELULA
Brief Summary:
The primary objective of this study is to evaluate the efficacy of Debio 4326 in suppressing serum luteinizing hormone LH to prepubertal levels 52 weeks after the first Debio 4326 injection in pediatric participants receiving gonadotropin-releasing hormone agonist GnRHa therapy for central precocious puberty CPP
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None