Developing protocol for hydroxyurea detection in plasma of sickle cell patients
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- STATUS
- Not Recruiting
Summary
We are conducting this study to develop a protocol for the detection of hydroxyurea plasma. Hydroxyurea is the only FDA approved disease-modifying agent for children with sickle cell disease, and requires careful titration to maximize clinical benefit and minimize adverse effects. Unfortunately, there is considerable variability in the maximum tolerated dose (MTD), and often a delay of 6 to 12 months until patients reach his or her MTD. The research team at Purdue is looking at developing a pharmacokinetic-pharmacodynamic model of hydroxyurea to help clinicians with optimizing the dose for every individual. For the pharmacokinetic study, we need to measure hydroxyurea concentration in plasma within 4-8 hours of taking the drug. The hydroxyurea detection will happen at Bindley Bioscience Center. In order to measure the hydroxyurea concentration in plasma, we need to develop the protocol for it.
Description
We are conducting this study to develop a protocol for the detection of hydroxyurea plasma. Hydroxyurea is the only FDA approved disease-modifying agent for children with sickle cell disease, and requires careful titration to maximize clinical benefit and minimize adverse effects. Unfortunately, there is considerable variability in the maximum tolerated dose (MTD), and often a delay of 6 to 12 months until patients reach his or her MTD. The research team at Purdue is looking at developing a pharmacokinetic-pharmacodynamic model of hydroxyurea to help clinicians with optimizing the dose for every individual. For the pharmacokinetic study, we need to measure hydroxyurea concentration in plasma within 4-8 hours of taking the drug. The hydroxyurea detection will happen at Bindley Bioscience Center. In order to measure the hydroxyurea concentration in plasma, we need to develop the protocol for it.
Details
| Condition | sickle cell disease |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX8679 |
| Last Modified on | 19 February 2024 |
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