Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00098059
First received: December 2, 2004
Last updated: April 18, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes Simplex |
Drug: Famciclovir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Herpes Simplex
Drug Information available for:
Famciclovir
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]A patient with multiple AEs within the primary system organ class is counted only once in total row.
Secondary Outcome Measures:
- Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. [ Time Frame: Day 1, after swallowing the dose. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Overall acceptability of study medication was determined by caretaker response.
| Enrollment: | 74 |
| Study Start Date: | February 2005 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Famciclovir, pediatric oral formulation
single-arm
|
Drug: Famciclovir
Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle
|
Eligibility| Ages Eligible for Study: | 1 Year to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098059
Locations
| 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 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by Novartis:
|
herpes simplex cold sores fever blisters |
children Famvir famciclovir |
Additional relevant MeSH terms:
|
Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Famciclovir |
2-Aminopurine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013