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Interim analysis showed positive results, it was difficult to include patients and also the fact that the grant for this project has ended, we have decided to complete the study before we had included the total number of 16 patients.
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Valacyclovir has replaced acyclovir in many clinical scenarios. Pharmacokinetic data support the use of oral valacyclovir in children, but practical problems exist in children having to take adult-dose tablets. A formulation with acceptable palatability, good pharmaceutical quality and possibility of flexible dosing is developed. Pharmacokinetic data of this formulation is missing.
The present study investigates the pharmacokinetics of valacyclovir oral solution in children by determine the area under the curve (AUC0-12), time above critical concentration (Ccrit), Cmax and Tmax of acyclovir.
Secondary, the safety profile of a single dose of valacyclovir oral solution will be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valacyclovir oral solution | Other | Valacyclovir oral solution as administered in standard of care. Dosage: 10 mg/kg BID for children weighing less than 40 kg and 500 mg BID for children weighing 40 kg or more. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valacyclovir | Drug | PK curve collection to determine acyclovir exposure after administration of valacyclovir oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve | Acyclovir area under the curve (12h) | 12 hours |
| Cmax | Maximum concentration of aciclovir | 12 hours |
| Tmax | Time to reach maximum concentration of aciclovir | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Number of adverse events | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prinses Maxima Centrum voor kinderoncologie | Utrecht | Netherlands |
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| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| D000073618 | Varicella Zoster Virus Infection |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077483 | Valacyclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
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Intervention is pharmacokinetic (PK) curve collection in children, two age groups
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| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |