Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04194086|
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : June 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Acute||Drug: posaconazole oral suspensions||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||December 30, 2020|
|Experimental: posaconazole as antifungal prophylaxis||
Drug: posaconazole oral suspensions
posaconazole oral suspensions（5mg/kg/d,tid) will be administered specially febrile neutropenia patients four times a day and blood samples will be taken any hours after the first dose at least Day 7.
- Number, type and grade of adverse events of posaconazole assessed by CTCAE v4.0 [ Time Frame: 1 year ]Number, type and grade of adverse events of posaconazole oral suspensions to children with leukemia assessed by CTCAE v4.0.
- Plasma posaconazole concentration monitoring and its pharmacokinetic [ Time Frame: 1 year ]Blood samples for determination of plasma posaconazole concentration will be collected predoses (just prior to a daily dose) on days 3, 7, 14 and 21. Anther concentration (include peak concentraton) will also be collected at least 7days after the first dose.
- Serious Adverse events and drug-related adverse events monitoring [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194086
|Contact: yang lihua, PhDemail@example.com|
|Contact: yu firstname.lastname@example.org|
|Zhujiang Hospital of Southern Medical University||Recruiting|
|Guanzhou, Guangdong, China|
|Contact: zhang tingting 0086-020-61643022 email@example.com|