Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection

Novartis

Status and phase: Completed; Phase 2

Conditions: Herpes Simplex

Treatments: Drug: famciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448227

CFAM810B2301

Details and patient eligibility

About

This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection

Enrollment: 18 patients

Sex: All

Ages: 1 month to 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients from 1 month up to 1 year of age with herpes simplex infection

Exclusion criteria

• Patients with gestational age less than 32 weeks. Patients unable to swallow. Patients with history of malabsorption or previous gastrointestinal surgery.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Famciclovir

Experimental group

Description:

Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.

Treatment:

Drug: famciclovir