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Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Subjects in the age group of 2 to less than 6 years will be included |
|
| Cohort 2 | Experimental | Subjects in the age group of 1 to less than 2 years will be included |
|
| Cohort 3 | Experimental | Subjects in the age group of 6 months to less than 1 year will be included |
|
| Cohort 4 | Experimental | Subjects in the age group of 3 months to less than 6 months will be included |
|
| Cohort 5 | Experimental | Subjects in the age group of 1 month to less than 3 months will be included |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valaciclovir | Drug | Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma acyclovir and valaciclovir concentrations pre-dose (within 15 minutes of dose administration) and at 0.5, 1, 2, 4 and 6 hours following administration of the valaciclovir oral suspension dose. | 0.5, 1, 2, 4 and 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication. | Up to Day 5 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35233 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bradley J, Scholtz F, Brennan C, Zhao H, Weller S. Pharmacokinetics and safety of single-dose valacyclovir oral suspension in infants and children with current or potential herpesvirus infection. Poster presentation, 45th Annual Meeting Infectious Disease | ||
| 20014952 | Background | Kimberlin DW, Jacobs RF, Weller S, van der Walt JS, Heitman CK, Man CY, Bradley JS. Pharmacokinetics and safety of extemporaneously compounded valacyclovir oral suspension in pediatric patients from 1 month through 11 years of age. Clin Infect Dis. 2010 Jan 15;50(2):221-8. doi: 10.1086/649212. |
| Label | URL |
|---|---|
| Results for study HS210914 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| HS210914 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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|
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| GSK Investigational Site | San Diego | California | 92123 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32209 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40503 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40202 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70112 | United States |
| GSK Investigational Site | Durham | North Carolina | 27705 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45229 | United States |
| GSK Investigational Site | Galveston | Texas | 77555-0653 | United States |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 7580206 | Chile |
| GSK Investigational Site | Brits | 2000 | South Africa |
| GSK Investigational Site | George | 6529 | South Africa |
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| HS210914 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HS210914 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HS210914 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HS210914 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HS210914 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HS210914 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077483 | Valacyclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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