Ignite Creation Date:
2024-05-06 @ 1:40 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04085523
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2019-09-09
Brief Title:
A Dose Escalation Trial Evaluating Safety Efficacy and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia
Sponsor:
Ascendis Pharma AS
Organization:
Ascendis Pharma AS
Study Overview
Official Title:
ACcomplisH A Phase 2 Multicenter Double-blind Randomized Placebo-controlled Dose Escalation Trial Evaluating Safety Efficacy and Pharmacokinetics of Subcutaneous Doses of TransCon CNP Administered Once Weekly for 52 Weeks in Prepubertal Children With Achondroplasia Followed by an Open-Label Extension Period
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
The trial is a multicenter double-blind randomized placebo-controlled dose escalation trial of weekly TransCon CNP administered subcutaneously in prepubertal children 2 to 10 years old inclusive with Achondroplasia
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