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

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Condition:	Herpes Simplex
Intervention:	Drug: Famciclovir

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Part A (Single-dose of Famciclovir)	Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.
Part B (Multiple-dose of Famciclovir)	Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.

Participant Flow: Overall Study

	Part A (Single-dose of Famciclovir)	Part B (Multiple-dose of Famciclovir)
STARTED	27	47
COMPLETED	27	46
NOT COMPLETED	0	1

Baseline Characteristics

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Reporting Groups

	Description
Part A (Single-dose of Famciclovir)	Each patient in Part A received a single dose of famciclovir (12.5 mg/kg).
Part B (Multiple-dose of Famciclovir)	Each patient in Part B received famciclovir twice a day (b.i.d.) approximately 12 hours apart for 7 days for a total of 14 doses. An 8-step dosing scheme (ranged from 150 mg b.i.d. to 500 mg b.i.d.) was used to determine the weight-based adjusted daily dose.

Baseline Measures

	Part A (Single-dose of Famciclovir)	Part B (Multiple-dose of Famciclovir)	Total
Number of Participants [units: participants]	27	47	74
Age, Customized [units: participants]
1 to <2 years	4	13	17
2 to <6 years	13	16	29
6 to 12 years	8	18	26
13 to 18 years	2	0	2
Gender [units: participants]
Female	17	24	41
Male	10	23	33

Outcome Measures

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1. Primary:

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) ]

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2. Primary:

Maximum Observed Plasma Concentration of Penciclovir (Cmax) [ plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]

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3. Primary:

Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax) [ Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]

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4. Primary:

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 ]

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5. Primary:

Apparent Oral Clearance of Penciclovir (CL/F) [ Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]

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Measure Type	Primary
Measure Title	Apparent Oral Clearance of Penciclovir (CL/F)
Measure Description	PK parameter; penciclovir is the active metabolite of famciclovir.
Time Frame	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes 26 of 27 patients enrolled in Part A of the study.

Reporting Groups

	Description
1 to < 2 Years	No text entered.
2 to <6 Years	No text entered.
6 to <13 Years	No text entered.
13 to <= 18 Years	Standard Deviation not reported for 13 to <=18 years group since there were only 2 patients enrolled in this group.

Measured Values

	1 to < 2 Years	2 to <6 Years	6 to <13 Years	13 to <= 18 Years
Number of Participants Analyzed [units: participants]	4	12	8	2
Apparent Oral Clearance of Penciclovir (CL/F) [units: L/h] Mean ± Standard Deviation	20.85 ± 8.5	25.1 ± 4.3	43.7 ± 9.6	68.8 ± 0

No statistical analysis provided for Apparent Oral Clearance of Penciclovir (CL/F)

6. Primary:

Apparent Terminal Elimination Half-life of Penciclovir (T1/2) [ Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]

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7. Primary:

Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. [ Administered 2 times daily over 7 days ]

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8. Secondary:

Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. [ Immediately after dose administration and 2-5 minutes later ]

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9. Secondary:

Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. [ Day 1 at clinic: after swallowing first dose ]

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10. Secondary:

Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study [ Day 8 at home: after swallowing last dose ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided by Novartis

Publications automatically indexed to this study:

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.

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CFAM810B2303
Study First Received:	December 2, 2004
Results First Received:	February 2, 2009
Last Updated:	May 7, 2009
ClinicalTrials.gov Identifier:	NCT00098059 History of Changes
Health Authority:	United States: Food and Drug Administration