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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:
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 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) ]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.
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. ]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.
| 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 (Child) |
| Sexes Eligible for Study: | All |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098059
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
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 |
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 Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 23, 2017