Pharmacokinetic Study of Sub-q and IV Treprostinil in Kids With Pulmonary Arterial Hypertension (PAH)
Trial ID or NCT#
Status
RECRUITING
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 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.
- 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.
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