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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00098059
First received: December 2, 2004
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
Results First Received: February 2, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Herpes Simplex
Intervention: Drug: Famciclovir

  Participant Flow
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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 The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.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.
Total Total of all reporting groups

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.   [ Time Frame: 8 hours and 24 hours after study drug administration (Part A) ]
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2.  Primary:   Maximum Observed Plasma Concentration of Penciclovir (Cmax)   [ Time Frame: 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)   [ Time Frame: 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-∞)   [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]
  Show Outcome Measure 4

5.  Primary:   Apparent Oral Clearance of Penciclovir (CL/F)   [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]
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6.  Primary:   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 ]
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7.  Primary:   Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.   [ Time Frame: 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.   [ Time Frame: Day 1, after swallowing the dose. ]
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9.  Secondary:   Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.   [ Time Frame: 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   [ Time Frame: 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:
unchecked 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.
unchecked 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.


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:


Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00098059     History of Changes
Other Study ID Numbers: CFAM810B2303
Study First Received: December 2, 2004
Results First Received: February 2, 2009
Last Updated: April 18, 2013
Health Authority: United States: Food and Drug Administration
Panama Minister of Health: Panama