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NCT04989686 · ClinicalTrials.gov registry record
Microsampling Assays for Immunosuppressive Drugs in Children
A clinical trial, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- 66
- Enrollment target
NCT04989686 is a clinical trial that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 66 participants.
The verdict
NCT04989686 has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- 66 participants
- Enrollment target
Study Summary
Immunosuppressive therapy is used to treat and manage solid organ and bone marrow/stem cell transplants in children. However, it can be harmful if too little or too much is given. Monitoring immunosuppressive drug (cyclosporine A, tacrolimus, and sirolimus) concentrations in the blood is important to ensure that the drug is given safely and effectively, but current approaches for collecting blood from a vein are painful and often difficult in children. Investigators seek to compare a new approach for monitoring immunosuppressive drug concentrations using a novel small volume blood sampling device, called Tasso-M20, to the traditional way of collecting blood from a vein. Additionally Investigators are interested in assessing patient and family perceptions of the Tasso-M20 device being used for immunosuppressive therapy and their comfortability using the device outside of a clinical setting. The primary objective of this project is to identify the relationship between cyclosporine A (CYA), tacrolimus (TAC), and sirolimus (SIR) concentrations in the venous blood (gold-standard) and capillary whole blood obtained using the microsampling device Tasso-M20. The secondary objective of this study is to investigate the stability of CYA, TAC, and SIR in blood samples collected using the Tasso-M20 device under the conditions of shipping and storage. The sub-study objective is to thematically compare subjects' and families' perceptions of blood collection via the Tasso-M20 device and standard venous blood collection.
Interventions
- OTHER Microsampling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2023-06-08 |
| Est. Completion | 2025-05-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04989686
The ClinicalTrials.gov registry entry for NCT04989686 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Microsampling is the first listed.
NCT04989686 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04989686 about?
NCT04989686 is a clinical study titled "Microsampling Assays for Immunosuppressive Drugs in Children". Immunosuppressive therapy is used to treat and manage solid organ and bone marrow/stem cell transplants in children. However, it can be harmful if too little or too much is given. Monitoring immunosuppressive drug (cyclosporine A, tacrolimus, and sirolimus) concentrations in the blood is important t...
What is the current status of trial NCT04989686?
This trial is currently completed. The enrollment target is 66 participants. The study started on 2023-06-08. Estimated completion is 2025-05-01.
What interventions are being tested in trial NCT04989686?
The interventions under investigation include: Microsampling (OTHER).
Who is sponsoring clinical trial NCT04989686?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
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