Ignite Creation Date:
2024-05-06 @ 3:33 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02318186
Status:
COMPLETED
Last Update Posted:
2017-10-05
First Post:
2014-01-09
Brief Title:
Pharmacokinetic Study of Sub-q and IV Treprostinil in Kids With Pulmonary Arterial Hypertension PAH
Sponsor:
Jeffrey A Feinstein
Organization:
Stanford University
Study Overview
Official Title:
Multi-center Open-label Pharmacokinetic Study of Subcutaneously and Intravenously Administered Treprostinil in Children With Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2017-10
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:
PKRemodulin
Brief Summary:
Abstract
This is a multi-center open-label pharmacokinetic PK study examining the relationship between the steady-state plasma concentration and dose of treprostinil delivered intravenously or subcutaneously in children with pulmonary arterial hypertension PAH Subjects will be divided into 5 cohorts by age A blood sample will be obtained from each subject at steady state Additional blood samples will be obtained from a small subset of subjects with a 15 increase or with at least a 15ngkgmin increase in dose from steady state Samples will be sent to a pharmacokinetic laboratory for analysis Linear regression analysis will be used to determine the relationship between the steady state plasma concentration and drug dose A power model will be used to assess dose proportionality
This is a multi-center open-label pharmacokinetic PK study examining the relationship between the steady-state plasma concentration and dose of treprostinil delivered intravenously or subcutaneously in children with pulmonary arterial hypertension PAH Subjects will be divided into 5 cohorts by age A blood sample will be obtained from each subject at steady state Additional blood samples will be obtained from a small subset of subjects with a 15 increase or with at least a 15ngkgmin increase in dose from steady state Samples will be sent to a pharmacokinetic laboratory for analysis Linear regression analysis will be used to determine the relationship between the steady state plasma concentration and drug dose A power model will be used to assess dose proportionality
Detailed Description:
Background Information and Rationale
Treprostinil has not been adequately studied to determine its safety and efficacy in children 16 years old However the drugs use and tolerance in children with PAH has been demonstrated in studies with small sample sizes
Although the pharmacokinetic relationship of treprostinil has been established in adult patients with PAH the relationship between the steady-state plasma concentration and dose for children requires further investigation because of physiologic differences such as the maturity of enzyme systems and drug clearance mechanisms between children and adults The subjects in this study will be divided into cohorts by age to address the physiologic changes that occur throughout childhood
Currently no data exists demonstrating the relationship between the steady-state plasma concentration and dose for children treated with intravenously or subcutaneously delivered treprostinil Understanding the pharmacokinetics of treprostinil among different age cohorts in children will provide the data to make an informed recommendation for dosing based on age and possibly weight
Treprostinil has not been adequately studied to determine its safety and efficacy in children 16 years old However the drugs use and tolerance in children with PAH has been demonstrated in studies with small sample sizes
Although the pharmacokinetic relationship of treprostinil has been established in adult patients with PAH the relationship between the steady-state plasma concentration and dose for children requires further investigation because of physiologic differences such as the maturity of enzyme systems and drug clearance mechanisms between children and adults The subjects in this study will be divided into cohorts by age to address the physiologic changes that occur throughout childhood
Currently no data exists demonstrating the relationship between the steady-state plasma concentration and dose for children treated with intravenously or subcutaneously delivered treprostinil Understanding the pharmacokinetics of treprostinil among different age cohorts in children will provide the data to make an informed recommendation for dosing based on age and possibly weight
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