A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Herpes Simplex

Treatments: Drug: Valaciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00297206

HS210914

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 1 month to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have a current herpes virus infection.
• Have neonatally acquired herpes at risk of potential recurrence.
• Immunocompromised or cancer patients at risk for development of a herpes virus infection.

Exclusion criteria

• Hypersensitivity to antiherpetic medications.
• Impaired hepatic or renal function.
• Show presence of other serious or unstable underlying disease.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 5 patient groups

Cohort 1

Experimental group

Description:

Subjects in the age group of 2 to less than 6 years will be included

Treatment:

Drug: Valaciclovir

Cohort 2

Experimental group

Description:

Subjects in the age group of 1 to less than 2 years will be included

Treatment:

Drug: Valaciclovir

Cohort 3

Experimental group

Description:

Subjects in the age group of 6 months to less than 1 year will be included

Treatment:

Drug: Valaciclovir

Cohort 4

Experimental group

Description:

Subjects in the age group of 3 months to less than 6 months will be included

Treatment:

Drug: Valaciclovir

Cohort 5

Experimental group

Description:

Subjects in the age group of 1 month to less than 3 months will be included

Treatment:

Drug: Valaciclovir