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VACV or granules

Phase 3

Herpes Simplex | Small molecule | Infectious Disease |GSK plc|Trials Updated: Aug 17, 2018

VACV or granules target and mechanism

ModalitySmall molecule

Also known as VACV tablets (Adults or pediatrics) or granules (pediatrics)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

VACV or granules clinical trials

VACV or granules · 1 trial · 1 indication

Phase 3 1
NCT01602562Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation PatientsHerpes Simplex
COMPLETED40 Analytics
PHASE3COMPLETED
Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients
Herpes SimplexUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With a Herpes Simplex Virus (HSV) Infection
From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)

Viral isolation/identification was conducted if the investigator (or subinvestigator) suspected HSV infection according to the relevant clinical symptoms (oral mucositis, skin infection, genital herpes, and pneumonia). If the result of viral isolation/identification was positive, the participant concerned was defined as a case of HSV infection. For reference, a virus deoxyribonucleic acid (DNA) identification (PCR) was simultaneously performed.

Secondary Endpoints

Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)
Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LD) Values at Screening, Day 14, and Day 35
Screening (SCR), Day 14, and Day 35
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35
Screening (SCR), Day 14, and Day 35
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
VACV (256U87; valaciclovir hydrochloride)EXPERIMENTALAdult patients (16-65 years): A VACV tablet (containing 500mg of valaciclovir) is orally given twice daily. Pediatric patients (1-16 years): VACV granules are orally given at a dose of 25 mg/kg b.w. twice daily. The maximum dose per treatment is limited to 500 mg. Pediatric patients weighing 40 kg or over may be orally given a VACV tablet (containing 500 mg of valaciclovir) twice daily.

Interventions

NameTypeDescription
VACV tablets (Adults or pediatrics) or granules (pediatrics)DRUGA white to slightly yellowish white film coated tablet contains 556 mg of valaciclovir hydrochloride (500 mg of valaciclovir)). VACV granules have no or slightly specific odor.
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Eligibility Criteria

Age Range1 Year to 64 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Patients who are planning to undergo hematopoietic stem cell transplantation, except cord blood transplantation. * Patients aged from 1 and above to under 65 at the time of informed consent. * Patients who can submit their voluntary written informed consent if they are 12 year...

Countries:Japan
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Frequently asked questions about VACV or granules

What is VACV used for?

VACV is an investigational small molecule developed by GSK plc for herpes simplex. It is being studied in a Phase 3 trial in Japan involving patients who have undergone hematopoietic stem cell transplantation. The trial enrolled 40 participants, including adults and pediatric patients aged 1 year and older.

Who makes VACV?

VACV is developed by GSK plc, which trades under the ticker GSK. The company is responsible for the clinical development of this small molecule for herpes simplex.

What phase is VACV in?

VACV is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The completed trial, NCT01602562, studied VACV in hematopoietic stem cell transplantation patients with herpes simplex in Japan.

What clinical trials is VACV in?

VACV has been studied in one completed Phase 3 trial, NCT01602562, titled Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients. The trial enrolled 40 participants in Japan and included patients aged 1 year and older with herpes simplex.

Is VACV the same as VACV tablets or granules?

Yes, VACV is also known as VACV tablets for adults or pediatrics, and VACV granules for pediatrics. These refer to the same investigational product developed by GSK plc for herpes simplex.