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

NCT02318186 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2017-10-05

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • United Therapeutics

    collaborator INDUSTRY

  • Seattle Children's Hospital

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • Jeffrey A. Feinstein

    lead OTHER

Principal Investigators

  • Jeffrey Feinstein, MD, MPH · Stanford University

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-08-01
Completion
2017-08-01

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02318186 on ClinicalTrials.gov