Herpes SimplexPhase 3NCT00098059
Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
A Phase 3 study testing Famciclovir in people with Herpes Simplex, run by Novartis Pharmaceuticals at 13 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Herpes Simplex
- What is being tested?
- Famciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Feb 2005to Dec 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- History or laboratory evidence of herpes simplex infection
- Clinical evidence or suspicion of herpes simplex infection
Who cannot join
- 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
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States11 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233-1711
Children's Memorial Hospital
Chicago, Illinois, 60614
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Children's Medical Center of Dallas
Dallas, Texas, 75235
The Children's Hospital
Denver, Colorado, 80218
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, 40202-3830
Columbia University Medical Center
New York, New York, 10032
State University of New York at
Stony Brook, New York, 11794-3362
Panama2 sites
Panama Minister of Health
David, Chiriquí Province
Panama Minister of Health
Panama City
About this study
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
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.
- Conditions
- Herpes Simplex
- Being tested
- Famciclovir
- Keywords
- herpes simplex, cold sores, fever blisters, children, Famvir, famciclovir
- Medical subject headings
- Herpes Simplex, Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamciclovirDrug
Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle
| Study group | Role | What they receive |
|---|---|---|
| Famciclovir, pediatric oral formulation | Experimental | single-arm Receives: Drug: Famciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
A patient with multiple AEs within the primary system organ class is counted only once in total row.
Measured: Administered 2 times daily over 7 days
Secondary outcomes (3)
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.
Measured: Day 1, after swallowing the dose.
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.
Measured: 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.
Measured: Day 8 at home: after swallowing last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2004 (estimated)
- Study startFeb 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes SimplexStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00098059
- Sponsor's protocol ID
- CFAM810B2303
- Status last verified
- Apr 2013
- First submitted
- 2 Dec 2004
- Last updated
- 25 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 19273678
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00098059
- Acronym / sponsor ID
- CFAM810B2303
- Conditions
- Herpes Simplex
- Keywords
- herpes simplex, cold sores, fever blisters, children, Famvir, famciclovir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 3 Dec 2004 (estimated)
- Results
- Posted 6 May 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Famciclovir, pediatric oral formulation | Experimental | Drug: Famciclovirsingle-arm |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- History or laboratory evidence of herpes simplex infection
- Clinical evidence or suspicion of herpes simplex infection
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FamciclovirFamciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle | Drug | Famciclovir, pediatric oral formulation |
Primary outcome
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.
3 secondary outcomes
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 Pediatric Oral Formulation by Patients in Part B of the Study.
Time frame: Day 1 at clinic: after swallowing first dose
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study
Time frame: Day 8 at home: after swallowing last dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19273678Saez-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.
Related trials for Herpes Simplex
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingObservational study
Genetic Studies of Chronic Active Epstein-Barr Disease
Chronic Active Epstein-Barr Virus
RecruitingObservational study
Natural History Study of GATA2 Deficiency and Related Disorders
GATA2 Deficiency
Not yet recruitingPhase 4
Aciclovir Versus Placebo for HSV-2 Meningitis
Herpes Simplex 2, Meningitis, Viral
Active, not recruitingPhase 1
A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
Genital Herpes Simplex Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Famciclovir in people with Herpes Simplex, run by Novartis Pharmaceuticals at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00098059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2013; AzTrials last refreshed its copy on 8 Nov 2026.