Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05929807
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-16
First Post:
2023-06-06
Brief Title:
A Clinical Trial to Investigate Long-term Safety Tolerability and Efficacy of Weekly Subcutaneous Doses With TransCon CNP in Children and Adolescents With Achondroplasia
Sponsor:
Ascendis Pharma Growth Disorders AS
Organization:
Ascendis Pharma AS
Study Overview
Official Title:
A Phase 2 Multicenter Long-Term Open Label Extension Trial Evaluating Safety Tolerability and Efficacy of Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children and Adolescents With Achondroplasia
Status:
ENROLLING_BY_INVITATION
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:
AttaCH
Brief Summary:
TransCon CNP administered once-weekly in children and adolescents with achondroplasia who have completed a prior TransCon CNP clinical trial Participants who complete a prior TransCon CNP trial and meet all eligibility criteria will be invited to continue into the long-term open label extension trial to receive 100 µg CNPkgweek of TransCon CNP Trial treatment will be completed when the participant reaches 16 years of age for females and 18 years of age for males and have femur and tibial epiphyseal closure TransCon CNP treatment will continue if femur and tibial epiphyseal closure is not confirmed at the age of 16 years for females and 18 years for males Treatment with TransCon CNP will be completed once femur and tibial epiphyseal closure is confirmed by radiographic imaging The trial duration is individual for each trial participant Visits will occur every 12-14 weeks throughout the trial
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