Ignite Creation Date:
2024-05-06 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05246033
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-02
First Post:
2022-02-09
Brief Title:
A Dose Escalation Trial Evaluating Safety Efficacy and Pharmacokinetics of Multiple Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children With Achondroplasia
Sponsor:
Ascendis Pharma AS
Organization:
Ascendis Pharma AS
Study Overview
Official Title:
ACcomplisH China A Phase 2 Multicenter Randomized Placebo-controlled Dose Escalation Trial Evaluating Safety Efficacy and Pharmacokinetics of Multiple Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children With Achondroplasia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
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:
Purpose of the study
The main purpose of this study is to determine the safety and evaluate the effect of a once weekly dose of TransCon CNP in prepubertal children with achondroplasia in China
Study Treatments
TransCon CNP is an investigational new drug which means that it is currently being tested and therefore is considered experimental TransCon CNP is designed to provide a sustained exposure of active CNP by subcutaneous under the skin injection once weekly
The Randomized Period of this study is a double-blinded and placebo-controlled Placebo-controlled means that some participants will receive injections that dont contain any TransCon CNP placebo injection - no active ingredient Double-blinded means that neither the participant nor the study doctor will know which treatment the participant will be receiving except in an emergency
After completion of the Randomized Period the trial participant may be invited to take part of the Open-Label Period of this study
Open-label means that all participants will receive injections that contain TransCon CNP regardless of which treatment TransCon CNP or placebo was assigned during the 52 weeks 1 year Randomized Periodblinded treatment period It also means that both the participant and the study doctor will know which treatment and which dose the participant receives
The main purpose of this study is to determine the safety and evaluate the effect of a once weekly dose of TransCon CNP in prepubertal children with achondroplasia in China
Study Treatments
TransCon CNP is an investigational new drug which means that it is currently being tested and therefore is considered experimental TransCon CNP is designed to provide a sustained exposure of active CNP by subcutaneous under the skin injection once weekly
The Randomized Period of this study is a double-blinded and placebo-controlled Placebo-controlled means that some participants will receive injections that dont contain any TransCon CNP placebo injection - no active ingredient Double-blinded means that neither the participant nor the study doctor will know which treatment the participant will be receiving except in an emergency
After completion of the Randomized Period the trial participant may be invited to take part of the Open-Label Period of this study
Open-label means that all participants will receive injections that contain TransCon CNP regardless of which treatment TransCon CNP or placebo was assigned during the 52 weeks 1 year Randomized Periodblinded treatment period It also means that both the participant and the study doctor will know which treatment and which dose the participant receives
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