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

Tracking Information

First Received Date ^ICMJE

December 2, 2004

Last Updated Date

May 7, 2009

Start Date ^ICMJE

February 2005

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and Tolerability of a Single-Dose of Famciclovir in Part A of the Study. [ Time Frame: 8 hours and 24 hours after study drug administration (Part A) ] [ Designated as safety issue: Yes ]
Maximum Observed Plasma Concentration of Penciclovir (Cmax) [ Time Frame: plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ] [ Designated as safety issue: No ]
Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax) [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ] [ Designated as safety issue: No ]
Area Under the Penciclovir Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ] [ Designated as safety issue: No ]
Apparent Oral Clearance of Penciclovir (CL/F) [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ] [ Designated as safety issue: No ]
Apparent Terminal Elimination Half-Life of Penciclovir (T1/2) [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ] [ Designated as safety issue: No ]
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. [ Time Frame: Administered 2 times daily over 7 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety
Blood levels

Change History

Complete list of historical versions of study NCT00098059 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. [ Time Frame: Immediately after dose administration and 2-5 minutes later ] [ Designated as safety issue: No ]
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. [ Time Frame: Day 1 at clinic: after swallowing first dose ] [ Designated as safety issue: No ]
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study [ Time Frame: Day 8 at home: after swallowing last dose ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Step A & B: acceptability of pediatric formulation by patients

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Herpes Simplex

Intervention ^ICMJE

Drug: Famciclovir

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

Study Arms / Comparison Groups

Famciclovir, pediatric oral formulation: Experimental

single-arm

Intervention: Drug: Famciclovir

Publications *

Sáez-Llorens X, Yogev R, Arguedas A, Rodriguez A, Spigarelli MG, De León Castrejón T, Bomgaars L, Roberts M, Abrams B, Zhou W, Looby M, Kaiser G, Hamed K. Pharmacokinetics and safety of famciclovir in children with herpes simplex or varicella-zoster virus infection. Antimicrob Agents Chemother. 2009 May;53(5):1912-20. Epub 2009 Mar 9.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Year to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Guatemala, Panama

Administrative Information

NCT ID ^ICMJE

NCT00098059

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study ID Numbers ^ICMJE

CFAM810B2303

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP