Viewing Study NCT06433557



Ignite Creation Date: 2024-06-16 @ 11:49 AM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06433557
Status: RECRUITING
Last Update Posted: 2024-06-12
First Post: 2024-05-23

Brief Title: A Phase 2 Clinical Trial to Evaluate Efficacy Safety and Tolerability of Navepegritide in Combination With Lonapegsomatropin in Children With Achondroplasia
Sponsor: Ascendis Pharma Growth Disorders AS
Organization: Ascendis Pharma AS

Study Overview

Official Title: A Phase 2 Open-Label Single-Arm 156-week Trial to Investigate the Efficacy Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children With Achondroplasia
Status: RECRUITING
Status Verified Date: 2024-08
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: COACH
Brief Summary: This proof-of-concept trial is being conducted to evaluate the efficacy safety and tolerability of combination treatment with navepegritide and lonapegsomatropin administered as separate subcutaneous SC injections once weekly in children with achondroplasia ACH aged 2 to 11 years
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