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valaciclovir granules

Phase 3

Varicella | Small molecule | Infectious Disease |GSK plc|Trials Updated: Apr 15, 2015

valaciclovir granules target and mechanism

ModalitySmall molecule

Also known as valaciclovir HCl granules

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

valaciclovir granules clinical trials

valaciclovir granules · 1 trial · 1 indication

Phase 3 1
NCT00169416Evaluation Of Valaciclovir In Patients With ChickenpoxVaricella
COMPLETED43 Analytics
PHASE3COMPLETED
Evaluation Of Valaciclovir In Patients With Chickenpox
VaricellaUnlock trial analytics

Study Endpoints

Primary Endpoints

Plasma aciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.

Secondary Endpoints

Plasma valaciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
valaciclovir HCl granulesDRUG -
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Eligibility Criteria

Age Range1 Year to 11 Years
SexALL
Healthy VolunteersNo

Inclusion criteria: * Subjects aged 1 year to less than 12 years with a clinical diagnosis of chickenpox within 48 hours of the onset of the rash. Exclusion criteria: * History of hypersensitivity reactions. * Impaired hepatic or renal function. * Gastrointestinal dysfunction. * Serious underlyin...

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Frequently asked questions about valaciclovir granules

What is valaciclovir granules used for?

Valaciclovir granules are an antiviral treatment being studied for varicella, commonly known as chickenpox. The granules are an oral formulation developed for patients with this infectious disease. GSK plc is the company developing the product, which has completed a Phase 3 trial in patients with chickenpox.

Who makes valaciclovir granules?

Valaciclovir granules are developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating the granules in varicella. The product is an oral small molecule antiviral formulation.

What phase is valaciclovir granules in?

Valaciclovir granules are in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The program is investigational and has not been approved by the FDA for varicella.

What clinical trials are being conducted with valaciclovir granules?

The valaciclovir granules program includes one completed Phase 3 trial, NCT00169416, titled Evaluation Of Valaciclovir In Patients With Chickenpox. The trial enrolled 43 patients with varicella, including children as young as 1 year old, and was an uncontrolled study.

Is valaciclovir granules the same as valaciclovir HCl granules?

Yes, valaciclovir granules are also known as valaciclovir HCl granules. Both names refer to the same GSK plc product being developed for varicella. The HCl form is the hydrochloride salt of valaciclovir used in the granule formulation.