Ignite Creation Date:
2024-05-06 @ 3:23 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02276872
Status:
COMPLETED
Last Update Posted:
2019-01-04
First Post:
2014-10-21
Brief Title:
Safety Tolerability and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
A Multicenter Open-Label 24-Week Uncontrolled Study to Evaluate the Safety Tolerability and Pharmacokinetics of Oral Treprostinil Extended Release Tablets Following Transition From Remodulin or Inhaled Prostacyclin Therapy or as Add-on to Current PAH Therapy in De Novo Prostacyclin Pediatric Subjects Aged 7 to 17 Years With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2018-12
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 was a multi-center open-label safety tolerability and pharmacokinetic study of oral treprostinil in pediatric subjects with stable PAH aged 7 to 17 years who were 1 transitioning from parenteral Remodulin therapy 2 transitioning from inhaled prostacyclin therapy or 3 not currently receiving prostacyclin therapy
Detailed Description:
Study TDE-PH-206 was a multicenter open-label study designed to investigate the safety tolerability and PK of oral treprostinil administered 3 times daily TID or 4 times daily QID at the discretion of the Investigator with food in pediatric PAH subjects aged 7 to 17 years of age 1 transitioning from continuous IVSC Remodulin 2 transitioning from inhaled prostacyclin or 3 as add-on to current PAH therapies in de novo prostacyclin subjects Eligible subjects were assigned to a cohort based upon their background therapy All subjects received oral treprostinil provided as 0125 025 1 or 25 mg extended-release tablets Subjects in Cohort 1 began the transition from IVSC Remodulin in the hospital with a goal of complete transition to oral treprostinil within 5 days The initial dose of oral treprostinil for Cohort 1 was calculated from the subjects dose of IVSC Remodulin and weight Subjects in Cohorts 2 and 3 were initiated on 0125 mg TID or QID oral treprostinil with dose escalations possible every 24 hours in increments of 0125 mg TID or QID at the discretion of the Investigator during the first 4 weeks and in increments of either 0125 mg or 025 mg every 24 hours thereafter Cross titration occurred for Cohorts 1 and 2 such that doses of IVSC Remodulin or inhaled prostacyclin were decreased as subjects were fully transitioned to oral treprostinil
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None