Ignite Creation Date:
2024-05-06 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03492177
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2018-04-03
Brief Title:
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Prospective Multicenter Open Label Single Arm Phase 2 Study to Investigate the Safety Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial Hypertension
Status:
ACTIVE_NOT_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:
The purpose of this study to confirm the selexipag starting doses selected based on pharmacokinetic PK extrapolation from adults that leads to similar exposure as adults doses in children from greater than or equal to 2 to less than 18 years of age with Pulmonary Arterial Hypertension PAH by investigating the PK of selexipag and its active metabolite ACT-333679 in this population
Detailed Description:
The selection of the starting dose for pediatric participants is based on the PK extrapolation from adults taking into account the children body weight category in order to lead to an exposure similar to that in adult PAH participants at a starting dose of 200 micrograms mcg As in adults selexipag will be up-titrated to the individual maximum tolerated dose iMTD during the first 12 weeks Approximately 60 participants will be enrolled in 3 different age cohorts to obtain at least 45 participants with evaluable PK profiles Cohort 1 12 to 18 years of age Cohort 2 6 to 12 years of age Cohort 3 2 to 6 years of age In each age cohort the starting dose will depend on the body weight Enrollment will start with both Cohort 1 and Cohort 2 After completion of PK assessments in at least 15 participants from Cohort 1 at Week 12 a first interim analysis will be conducted to establish the dose-exposure relationship using a population PK model The PK data from any participants in Cohort 2 who have completed their PK assessments at this time will be included in this first interim analysis Results of this model-based analysis will be used to confirm or adjust the selexipag doses initially selected Enrollment of Cohort 3 children 2 to 6 years of age will start once the appropriate doses have been confirmed in a second interim analysis of PK data from Cohorts 1 and 2 and if there is no safety concern based on review by an Independent Data Monitoring Committee IDMC
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-000145-39 | EUDRACT_NUMBER | None | None |
| AC-065A203 | OTHER | Actelion | None |