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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Famciclovir, pediatric oral formulation | Experimental | single-arm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famciclovir | Drug | Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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 |
| 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 |
| Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞) | PK parameter; penciclovir is the active metabolite of famciclovir. | Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose |
| 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 |
| 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 |
| Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233-1711 | United States | ||
| The Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19273678 | Derived | Saez-Llorens X, Yogev R, Arguedas A, Rodriguez A, Spigarelli MG, De Leon Castrejon 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. doi: 10.1128/AAC.01054-08. Epub 2009 Mar 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 |
Overall acceptability of the study medication was determined by caretaker response. |
| Day 1 at clinic: after swallowing first dose |
| 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 |
| Denver |
| Colorado |
| 80218 |
| United States |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | United States |
| Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky | 40202-3830 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| State University of New York at | Stony Brook | New York | 11794-3362 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Children's Medical Center of Dallas | Dallas | Texas | 75235 | United States |
| Baylor College of Medicine/Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Panama Minister of Health | David | Chiriquí Province | Panama |
| Panama Minister of Health | Panama City | Panama |
| FG001 |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A (Single-dose of Famciclovir) | Each patient in Part A received a single dose of famciclovir (12.5 mg/kg). |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Includes all 27 patients enrolled in Part A of the study. | Posted | Number | participants | Day 1, after swallowing the dose. |
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| 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. | Includes all 47 patients enrolled in Part B of the study. | Posted | Number | participants | Day 1 at clinic: after swallowing first dose |
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| 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. | Includes all 47 patients enrolled in Part B of the study. Response was not available for 1 patient in the 2 to <6 years and 6 to <=12 years groups. | Posted | Number | participants | Day 8 at home: after swallowing last dose |
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| 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. | Includes all 27 patients enrolled in Part A of the study. | Posted | Number | participants | 8 hours and 24 hours after study drug administration (Part A) |
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| Primary | Maximum Observed Plasma Concentration of Penciclovir (Cmax) | PK parameter; penciclovir is the active metabolite of famciclovir. | Includes all 27 patients enrolled in Part A of the study. | Posted | Mean | Full Range | μg/mL | plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose |
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| Primary | Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax) | PK parameter; penciclovir is the active metabolite of famciclovir. | Includes all 27 patients enrolled in Part A of the study. | Posted | Median | Full Range | hours | Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose |
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| Primary | Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞) | PK parameter; penciclovir is the active metabolite of famciclovir. | Includes 26 of 27 patients enrolled in Part A of the study. | Posted | Mean | Full Range | (μg/mL)h | Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose |
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| Primary | Apparent Oral Clearance of Penciclovir (CL/F) | PK parameter; penciclovir is the active metabolite of famciclovir. | Includes 26 of 27 patients enrolled in Part A of the study. | Posted | Mean | Full Range | L/h | Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose |
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| Primary | Apparent Terminal Elimination Half-life of Penciclovir (T1/2) | PK parameter; penciclovir is the active metabolite of famciclovir | Includes 26 of 27 patients enrolled in Part A of the study. | Posted | Mean | Full Range | hours | Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose |
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| 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. | Includes 47 patients enrolled in Part B of the study. | Posted | Number | participants | Administered 2 times daily over 7 days |
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Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 27 | 5 | 27 | ||
| EG001 | 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. | 0 | 47 | 23 | 47 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| D006560 | Herpes Labialis |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000077595 | Famciclovir |
| ID | Term |
|---|---|
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Title | Measurements |
|---|---|
|
| 6 to <=12 years |
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| 13 to <=18 years |
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| Male |
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| Neither bad nor good |
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| Well |
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