Pharmacokinetic Study of Sub-q and IV Treprostinil in Kids With Pulmonary Arterial Hypertension (PAH)

Completed

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT02318186

Run by

Jeffrey A. Feinstein

People needed

51

Starts

2013-10-01

Expected to finish

2017-08-01

Last updated by the study team

2017-10-05

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patients must be between the ages of 0 to 16 years at the time of study enrollment.
• Written informed consent and assent, when applicable, must be completed.

You may not qualify if…

• Patients with severe liver or renal diseases.
• Female patients who may be pregnant or breastfeeding
• Written informed consent and assent not completed due to patient and/or parent or legal guardian unwilling to participate.
• Patients on concomitant use of a CYP2C inhibitor or inducer.

Where it is running

• Lucille Packard Children's Hospital — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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