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

Herpes Simplex Clinical Trial

Official title:

A Multicenter, Open-label, Single-arm, Two-step Study to Evaluate the Safety and Single-dose Pharmacokinetics of Famciclovir and Multiple-dose Safety After Administration of Famciclovir Oral Pediatric Formulation to Children 1 to 12 Years of Age With Herpes Simplex Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00098059
• Other study ID #: CFAM810B2303
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2004
• Last updated: April 18, 2013
• Start date: February 2005
• Est. completion date: December 2007

Study information

• Verified date: April 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPanama Minister of Health: Panama
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 12 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Simplex

Intervention

Drug:
• Famciclovir
Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle

Locations

Country	Name	City	State
Panama	Panama Minister of Health	Ciudad de David	Chiriqui
Panama	Panama Minister of Health	Ciudad de Panama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Children's Memorial Hospital	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	The Children's Hospital	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College of Medicine/Texas Children's Hospital	Houston	Texas
United States	Kosair Charities Pediatric Clinical Research Unit	Louisville	Kentucky
United States	Columbia University Medical Center	New York	New York
United States	State University of New York at	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.	A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.	8 hours and 24 hours after study drug administration (Part A)	No
Primary	Maximum Observed Plasma Concentration of Penciclovir (Cmax)	PK parameter; penciclovir is the active metabolite of famciclovir.	plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	No
Primary	Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)	PK parameter; penciclovir is the active metabolite of famciclovir.	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	No
Primary	Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-8)	PK parameter; penciclovir is the active metabolite of famciclovir.	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	No
Primary	Apparent Oral Clearance of Penciclovir (CL/F)	PK parameter; penciclovir is the active metabolite of famciclovir.	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	No
Primary	Apparent Terminal Elimination Half-life of Penciclovir (T1/2)	PK parameter; penciclovir is the active metabolite of famciclovir	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	No
Primary	Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.	A patient with multiple AEs within the primary system organ class is counted only once in total row.	Administered 2 times daily over 7 days	No
Secondary	Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.	Overall acceptability of the study medication was determined by caretaker response.	Day 1, after swallowing the dose.	No
Secondary	Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.	Overall acceptability of the study medication was determined by caretaker response.	Day 1 at clinic: after swallowing first dose	No
Secondary	Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study	Overall acceptability of study medication was determined by caretaker response.	Day 8 at home: after swallowing last dose	No