Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

Phase 3

Completed

• Conditions: Herpes Simplex
• Interventions: Drug: Famciclovir

• Registration Number: NCT00098059
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-12-02
• Study First Submitted QC: 2004-12-02
• Study First Posted: 2004-12-03
• Study Start: 2005-02
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2009-02-02
• Results First Submitted QC: 2009-03-20
• Results First Posted: 2009-05-06
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-18
• Last Update Posted: 2013-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• History or laboratory evidence of herpes simplex infection
• Clinical evidence or suspicion of herpes simplex infection

Exclusion Criteria

• Patients unable to swallow
• Concomitant use of probenecid
• Positive pregnancy test

Additional protocol-defined inclusion/exclusion criteria may apply. For detailed information on eligibility, please contact the study center nearest to you or call the following numbers: 1-862-778-3544 or 1-434-951-3228

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Famciclovir, pediatric oral formulation	Famciclovir	single-arm

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.	8 hours and 24 hours after study drug administration (Part A)	A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.
Maximum Observed Plasma Concentration of Penciclovir (Cmax)	plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	PK parameter; penciclovir is the active metabolite of famciclovir.
Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	PK parameter; penciclovir is the active metabolite of famciclovir.
Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	PK parameter; penciclovir is the active metabolite of famciclovir.
Apparent Oral Clearance of Penciclovir (CL/F)	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	PK parameter; penciclovir is the active metabolite of famciclovir.
Apparent Terminal Elimination Half-life of Penciclovir (T1/2)	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	PK parameter; penciclovir is the active metabolite of famciclovir
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.	Administered 2 times daily over 7 days	A patient with multiple AEs within the primary system organ class is counted only once in total row.

Secondary Outcome Measures

Name	Time	Method
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.	Day 1, after swallowing the dose.	Overall acceptability of the study medication was determined by caretaker response.
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.	Day 1 at clinic: after swallowing first dose	Overall acceptability of the study medication was determined by caretaker response.
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study	Day 8 at home: after swallowing last dose	Overall acceptability of study medication was determined by caretaker response.

Trial Locations

Locations (12)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Children's Medical Center of Dallas; 🇺🇸 Dallas, Texas, United States

Baylor College of Medicine/Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Panama Minister of Health; 🇵🇦 Ciudad de Panama, Panama

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

State University of New York at; 🇺🇸 Stony Brook, New York, United States

The Children's Hospital; 🇺🇸 Denver, Colorado, United States

Kosair Charities Pediatric Clinical Research Unit; 🇺🇸 Louisville, Kentucky, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Children's Memorial Hospital; 🇺🇸 Chicago, Illinois, United States