Clinical trial NCT00448227: Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection
Official title: A Multicenter, Open-label, Single-arm Study to Evaluate the Single-dose Pharmacokinetics, Acceptability and Safety of Famciclovir Oral Pediatric Formulation in Infants 1 Month to Less Than 1 Year of Age With Herpes Simplex Virus Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Simplex
Keywords: Infants, Herpes simplex infection
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-03-16
Enrollment: 18
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetics of Single Dose - Tmax
timeFrame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
measure: Pharmacokinetics of Single Dose - Cmax
timeFrame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
measure: Pharmacokinetics of Single Dose - AUC(0-tlast)
timeFrame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
measure: Pharmacokinetics of Single Dose - AUC(0-6h)
timeFrame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Secondary outcomes:
measure: Safety Assessed by AEs, SAEs
timeFrame: 38 days
measure: Safety Assessed by Labs
timeFrame: 2 days
measure: Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel.
timeFrame: 30 minutes after dosing
measure: Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver
timeFrame: Immediately after dosing
measure: Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel
timeFrame: Immediately after dosing
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pediatric Infectious Disease Of University of Alabama
state: Alabama
city: Chicago
country: United States
facility: Children's Memorial Hospital Chicago
state: Illinois
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Omaha
country: United States
facility: Archana Chatterjee
state: Nebraska
city: Cleveland
country: United States
facility: University Hospital Cased Medical Center Rainbow Babies and Children's Hospital
state: Ohio
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Novartis
name: Novartis
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Cased Medical Center Rainbow Babies and Children's Hospital, Cleveland, OH
name: Dr. Jeffery L. Blumer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blumer J, Rodriguez A, Sanchez PJ, Sallas W, Kaiser G, Hamed K. Single-dose pharmacokinetics of famciclovir in infants and population pharmacokinetic analysis in infants and children. Antimicrob Agents Chemother. 2010 May;54(5):2032-41. doi: 10.1128/AAC.01508-09. Epub 2010 Feb 16.