Trial Search Results
Pharmacokinetic Study of Sub-q and IV Treprostinil in Kids With Pulmonary Arterial Hypertension (PAH)
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.
Stanford is currently accepting patients for this trial.
Jeffrey A. Feinstein
Collaborator: United Therapeutics
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.
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.
Ages Eligible for Study
N/A - 18 Years
Genders Eligible for Study