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NCT03609840 · ClinicalTrials.gov registry record

Study of Thiotepa and TEPA Drug Exposure in Pediatric Hematopoietic Stem Cell Transplant Patients

A clinical trial, sponsored by University of California, San Francisco.

Completed
Registry status
25
Enrollment target

NCT03609840: Completed study, sponsored by University of California, San Francisco.

NCT03609840 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03609840 has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
25 participants
Enrollment target

Study Summary

Thiotepa is a chemotherapy drug used extensively in bone marrow transplantation. Thiotepa is a prodrug that undergoes metabolic conversion in the liver by CYP2B6 and CYP3A4 to its primary active metabolite, triethylene phosphoramide (TEPA). The goal of this study is to determine what causes some children to have different drug concentrations of thiotepa and TEPA in their bodies and if drug levels are related to whether or not a child experiences severe side-effects during their bone marrow transplant. The hypothesis is that certain clinical and genetic factors cause changes in thiotepa and TEPA drug levels in pediatric bone marrow transplant patients and that high levels may cause severe side-effects.

Primary Outcome

Area-under-the-curve (AUC) will be derived from the empirical Bayes estimates of individual clearance

Interventions

  • DRUG Thiotepa

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2017-05-24
Est. Completion 2023-07-31

What the finished NCT03609840 record still lists

NCT03609840 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Thiotepa is the first listed.

NCT03609840 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03609840 about?

NCT03609840 is a clinical study titled "Study of Thiotepa and TEPA Drug Exposure in Pediatric Hematopoietic Stem Cell Transplant Patients". Thiotepa is a chemotherapy drug used extensively in bone marrow transplantation. Thiotepa is a prodrug that undergoes metabolic conversion in the liver by CYP2B6 and CYP3A4 to its primary active metabolite, triethylene phosphoramide (TEPA). The goal of this study is to determine what causes some chi...

What is the current status of trial NCT03609840?

This trial is currently completed. The enrollment target is 25 participants. The study started on 2017-05-24. Estimated completion is 2023-07-31.

What interventions are being tested in trial NCT03609840?

The interventions under investigation include: Thiotepa (DRUG).

Who is sponsoring clinical trial NCT03609840?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03609840, the US trial registry maintained by the National Library of Medicine. NCT03609840 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.