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Pharmacokinetic Study of Sub-q and IV Treprostinil in Kids With Pulmonary Arterial Hypertension (PAH)
Recruiting
I'm InterestedTrial ID: NCT02318186
Purpose
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 15ng/kg/min 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.
Official Title
Multi-center, Open-label Pharmacokinetic Study of Subcutaneously and Intravenously Administered Treprostinil in Children With Pulmonary Arterial Hypertension (PAH)
Eligibility
Inclusion Criteria:
1. Patients must be on continuous intravenous or subcutaneous treprostinil for the
treatment of pulmonary arterial hypertension, defined as mean pulmonary artery
pressure >25mmHg at rest with a PVRi > 3 Wood units.
2. Patients must be between the ages of 0 to 16 years at the time of study enrollment.
3. Written informed consent and assent, when applicable, must be completed.
Exclusion Criteria:
1. Patients with severe liver or renal diseases.
2. Female patients who may be pregnant or breastfeeding
3. Written informed consent and assent not completed due to patient and/or parent or
legal guardian unwilling to participate.
4. Patients on concomitant use of a CYP2C inhibitor or inducer.
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305