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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Herpes Simplex

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Famciclovir

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.

Group Type EXPERIMENTAL

famciclovir

Intervention Type DRUG

Administered orally as a single individualized dose between 25-200 mg based on body weight.

Interventions

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famciclovir

Administered orally as a single individualized dose between 25-200 mg based on body weight.

Intervention Type DRUG

Other Intervention Names

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Famvir

Eligibility Criteria

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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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No