Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
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ClinicalTrials.gov Identifier: NCT00098059 |
Recruitment Status :
Completed
First Posted : December 3, 2004
Results First Posted : May 6, 2009
Last Update Posted : April 25, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Herpes Simplex | Drug: Famciclovir | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 74 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Famciclovir, pediatric oral formulation
single-arm
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Drug: Famciclovir
Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle |
- 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) ]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) [ Time Frame: 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) [ Time Frame: 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-∞) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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. [ Time Frame: 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.
- Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: Day 8 at home: after swallowing last dose ]Overall acceptability of study medication was determined by caretaker response.

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Ages Eligible for Study: | 1 Year to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098059
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35233-1711 | |
United States, Colorado | |
The Children's Hospital | |
Denver, Colorado, United States, 80218 | |
United States, Illinois | |
Children's Memorial Hospital | |
Chicago, Illinois, United States, 60614 | |
United States, Kentucky | |
Kosair Charities Pediatric Clinical Research Unit | |
Louisville, Kentucky, United States, 40202-3830 | |
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
State University of New York at | |
Stony Brook, New York, United States, 11794-3362 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229-3039 | |
University Hospitals of Cleveland | |
Cleveland, Ohio, United States, 44106 | |
United States, Texas | |
Children's Medical Center of Dallas | |
Dallas, Texas, United States, 75235 | |
Baylor College of Medicine/Texas Children's Hospital | |
Houston, Texas, United States, 77030 | |
Panama | |
Panama Minister of Health | |
Ciudad de David, Chiriqui, Panama | |
Panama Minister of Health | |
Ciudad de Panama, Panama |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | External Affairs, Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00098059 |
Other Study ID Numbers: |
CFAM810B2303 |
First Posted: | December 3, 2004 Key Record Dates |
Results First Posted: | May 6, 2009 |
Last Update Posted: | April 25, 2013 |
Last Verified: | April 2013 |
herpes simplex cold sores fever blisters |
children Famvir famciclovir |
Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases |
Famciclovir Antiviral Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |