Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Jeffrey A. Feinstein

Collaborator: Children's Hospital of Philadelphia

Stanford Investigator(s):

Phase:

N/A

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.

Ages Eligible for Study

N/A - 18 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting