A Phase 1 interventional study of Valaciclovir in Herpes Simplex, sponsored by GlaxoSmithKline. Completed at 13 sites in 3 countries. Open to participants aged 1 Month to 6 Years. Per ClinicalTrials.gov, last updated 2017-09-11.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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.
305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.
This study's enrollment of 36 is below the median of 101 across 227 interventional studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Subjects in the age group of 2 to less than 6 years will be included
Drug: Valaciclovir
Subjects in the age group of 1 to less than 2 years will be included
Drug: Valaciclovir
Subjects in the age group of 6 months to less than 1 year will be included
Drug: Valaciclovir
Subjects in the age group of 3 months to less than 6 months will be included
Drug: Valaciclovir
Subjects in the age group of 1 month to less than 3 months will be included
Drug: Valaciclovir
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.
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.
Time frame: 0.5, 1, 2, 4 and 6 hours
Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication.
Time frame: Up to Day 5
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline