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Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

About

Brief Summary

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

Study Type
Observational

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
0 Years
Maximum Age
20 Years

Inclusion Criteria:

  • Participant is < 21 years of age
  • Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
  • (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment

Exclusion Criteria:

  • Participant has a known pregnancy Below exclusion criteria apply only to participants receiving one or more of the study drugs of interest at the time of enrollment,
  • Has had intermittent dialysis within previous 24 hours
  • Has had a kidney transplant within previous 30 days
  • Has had a liver transplant within previous 1 year
  • Has had a stem cell transplant within previous 1 year
  • Has had therapeutic hypothermia within previous 24 hours
  • Has had plasmapheresis within the previous 24 hours
  • Has a Ventricular Assist Device
  • Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Join this Trial

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Study Stats
Protocol No.
21-000335
Category
Pediatrics
Other
Contact
BRIANA CAMPOS
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04278404
For detailed technical eligibility, visit ClinicalTrials.gov.