Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06079398
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2023-10-06
Brief Title:
A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared with Placebo in Infants 0 to 2 Years of Age with Achondroplasia
Sponsor:
Ascendis Pharma Growth Disorders AS
Organization:
Ascendis Pharma AS
Study Overview
Official Title:
A Phase 2 Multicenter Double-Blind Randomized Placebo-controlled Trial Evaluating Safety Tolerability and Efficacy of Subcutaneous Doses of TransCon CNP Administered Once Weekly for 52 Weeks in Infants 0 to 2 Years of Age with Achondroplasia Followed by an Open Label Extension OLE Period
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This trial is a Phase 2 multicenter double-blind randomized ratio 21 TransCon CNP vs placebo placebo-controlled trial designed to evaluate the safety tolerability and efficacy of 100 μg CNPkg of Navepegritide TransCon CNP administered SC once-weekly for 52 weeks in infants with genetically verified heterozygous ACH aged 0 to 2 years at the time of randomization
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