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This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Famciclovir | Experimental | Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| famciclovir | Drug | Administered orally as a single individualized dose between 25-200 mg based on body weight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Single Dose - Tmax | Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached. | Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. |
| Pharmacokinetics of Single Dose - Cmax | Measured by Cmax - The maximum plasma concentration of study medication | Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. |
| Pharmacokinetics of Single Dose - AUC(0-tlast) | Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint. | Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. |
| Pharmacokinetics of Single Dose - AUC(0-6h) | Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample). | Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessed by AEs, SAEs | AEs and SAEs were collected during patient's stay in the clinic for PK sampling up to Hour 8, then at day 2 visit, 8 days(safety follow-up call) and 38 days (safety follow-up call) post dose. | 38 days |
| Safety Assessed by Labs |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Principal Investigator |
| Dr. Jeffery L. Blumer | University Hospital Cased Medical Center Rainbow Babies and Children's Hospital, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Infectious Disease Of University of Alabama | Birmingham | Alabama | United States | |||
| Children's Memorial Hospital Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20160046 | Derived | Blumer J, Rodriguez A, Sanchez PJ, Sallas W, Kaiser G, Hamed K. Single-dose pharmacokinetics of famciclovir in infants and population pharmacokinetic analysis in infants and children. Antimicrob Agents Chemother. 2010 May;54(5):2032-41. doi: 10.1128/AAC.01508-09. Epub 2010 Feb 16. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Famciclovir | Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory. |
| 2 days |
| Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel. | Tolerability was assessed by the study personnel 30 minutes after dosing using the following scale:
| 30 minutes after dosing |
| Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver | Assessed by the caregiver using a 5-point scale immediately after dosing:
| Immediately after dosing |
| Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel | Assessed by the study personnel using a 5-point scale after dosing:
| Immediately after dosing |
| Chicago |
| Illinois |
| United States |
| Children's Hospital of Michigan | Detroit | Michigan | United States |
| Archana Chatterjee | Omaha | Nebraska | 68131 | United States |
| University Hospital Cased Medical Center Rainbow Babies and Children's Hospital | Cleveland | Ohio | United States |
| UT Southwestern Medical Center | Dallas | Texas | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Famciclovir | Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | months |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics of Single Dose - Tmax | Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached. | Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration. | Posted | Median | Full Range | hours | Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. |
|
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| Secondary | Safety Assessed by AEs, SAEs | AEs and SAEs were collected during patient's stay in the clinic for PK sampling up to Hour 8, then at day 2 visit, 8 days(safety follow-up call) and 38 days (safety follow-up call) post dose. | Not Posted | 38 days | ||||||||||||||||||||||||||||||||||||||
| Secondary | Safety Assessed by Labs | Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory. | Not Posted | 2 days | ||||||||||||||||||||||||||||||||||||||
| Secondary | Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel. | Tolerability was assessed by the study personnel 30 minutes after dosing using the following scale:
| Safety population. | Posted | Number | Participants | 30 minutes after dosing |
| ||||||||||||||||||||||||||||||||||
| Secondary | Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver | Assessed by the caregiver using a 5-point scale immediately after dosing:
| Safety population. | Posted | Number | Participants | Immediately after dosing |
| ||||||||||||||||||||||||||||||||||
| Primary | Pharmacokinetics of Single Dose - Cmax | Measured by Cmax - The maximum plasma concentration of study medication | Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration. | Posted | Mean | Standard Deviation | μg/mL | Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. |
| |||||||||||||||||||||||||||||||||
| Primary | Pharmacokinetics of Single Dose - AUC(0-tlast) | Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint. | Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration. | Posted | Mean | Standard Deviation | (μg/mL)•h | Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. |
| |||||||||||||||||||||||||||||||||
| Primary | Pharmacokinetics of Single Dose - AUC(0-6h) | Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample). | Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration. | Posted | Mean | Standard Deviation | (μg/mL)•h | Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. |
| |||||||||||||||||||||||||||||||||
| Secondary | Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel | Assessed by the study personnel using a 5-point scale after dosing:
| Safety population. | Posted | Number | Participants | Immediately after dosing |
|
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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 | Famciclovir | Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight. | 1 | 18 | 8 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Condition aggravated | General disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Encephalitis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA | Systematic Assessment |
|
There is typically a disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| 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 |
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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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| 6 to 12 months |
|
| OG003 | Total |
|
|
Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight. |
| OG003 | Total |
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Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight. |
| OG003 | Total |
|
|