Herpes SimplexPhase 2NCT00448227

Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection

A Phase 2 study testing famciclovir in people with Herpes Simplex, run by Novartis at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection Read more about this study

Who is it for?: Ages 1 month to 1 year
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: 18 participants
Where: 6 sitesUnited States
Study dates: Oct 2007to Nov 2008
Phase: Phase 2
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 month to 1 year
All sexes
No healthy volunteers
Child

Who may be able to join

Male and female patients from 1 month up to 1 year of age with herpes simplex infection

Who cannot join

Patients with gestational age less than 32 weeks. Patients unable to swallow. Patients with history of malabsorption or previous gastrointestinal surgery.
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Pediatric Infectious Disease Of University of Alabama
Birmingham, Alabama
Children's Memorial Hospital Chicago
Chicago, Illinois
University Hospital Cased Medical Center Rainbow Babies and Children's Hospital
Cleveland, Ohio
UT Southwestern Medical Center
Dallas, Texas
Children's Hospital of Michigan
Detroit, Michigan
Archana Chatterjee
Omaha, Nebraska, 68131

Other trials in United States

About this study

Official title: A Multicenter, Open-label, Single-arm Study to Evaluate the Single-dose Pharmacokinetics, Acceptability and Safety of Famciclovir Oral Pediatric Formulation in Infants 1 Month to Less Than 1 Year of Age With Herpes Simplex Virus Infections

This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection

Conditions: Herpes Simplex
Being tested: famciclovir
Keywords: Infants, Herpes simplex infection
Medical subject headings: Herpes Simplex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

famciclovirDrug
Also called Famvir
Administered orally as a single individualized dose between 25-200 mg based on body weight.

Study groups in NCT00448227
Study group	Role	What they receive
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. Receives: Drug: famciclovir

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics of Single Dose - Tmax
Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.
Measured: 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
Measured: 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.
Measured: 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).
Measured: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.

Secondary outcomes (5)

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.
Measured: 38 days
Safety Assessed by Labs
Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory.
Measured: 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:
1. Significant emesis occurred,
2. Infant spit out most of the dose ingesting less than half of what was administered,
3. Infant spit out some of the dose, but ingested at least 50% of what was administered,
4. Infant was able to ingest and retain the dose administered
Measured: 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:
1. Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation
2. Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose
3. Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose
4. Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose
5. Very well accepted: infant appeared eager and ingested most of dose without special coaxing
Measured: 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:
1. Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation
2. Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose
3. Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose
4. Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose
5. Very well accepted: infant appeared eager and ingested most of dose without special coaxing
Measured: Immediately after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Nov 2008

First posted16 Mar 2007 (estimated)
Study startOct 2007
Primary completionNov 2008

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.
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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00448227
Sponsor's protocol ID: CFAM810B2301
Status last verified: Feb 2011
First submitted: 15 Mar 2007
Last updated: 11 Feb 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 20160046

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
Not yet recruitingPhase 2
Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
HSV-2 Infection

All Herpes Simplex trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label, Single-arm Study to Evaluate the Single-dose Pharmacokinetics, Acceptability and Safety of Famciclovir Oral Pediatric Formulation in Infants 1 Month to Less Than 1 Year of Age With Herpes Simplex Virus Infections
ClinicalTrials.gov ID: NCT00448227
Acronym / sponsor ID: CFAM810B2301
Conditions: Herpes Simplex
Keywords: Infants, Herpes simplex infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Nov 2008 (actual)
First posted: 16 Mar 2007 (estimated)
Results: Posted 14 Dec 2010

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 acceptability and safety of famciclovir in infants with herpes simplex infection

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Famciclovir	Experimental	Drug: famciclovirFamciclovir 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.

Who may qualify

Ages: 1 month to 1 year
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Male and female patients from 1 month up to 1 year of age with herpes simplex infection

Key exclusion criteria (2 listed)

Patients with gestational age less than 32 weeks. Patients unable to swallow. Patients with history of malabsorption or previous gastrointestinal surgery.
Other protocol-defined inclusion/exclusion criteria may apply.

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
famciclovirAlso: FamvirAdministered orally as a single individualized dose between 25-200 mg based on body weight.	Drug	Famciclovir

Primary outcome

Pharmacokinetics of Single Dose - Tmax
Time frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.
Pharmacokinetics of Single Dose - Cmax
Time frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Measured by Cmax - The maximum plasma concentration of study medication
Pharmacokinetics of Single Dose - AUC(0-tlast)
Time frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.
Pharmacokinetics of Single Dose - AUC(0-6h)
Time frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
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).

5 secondary outcomes

Safety Assessed by AEs, SAEs
Time frame: 38 days
Safety Assessed by Labs
Time frame: 2 days
Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel.
Time frame: 30 minutes after dosing
Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver
Time frame: Immediately after dosing
Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel
Time frame: Immediately after dosing

Results and safety

Results posted to the registry on 14 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Famciclovir	18	18

Primary outcome: Pharmacokinetics of Single Dose - Tmax

Time frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.. Median (Full Range). Unit: hours

Measure	Famciclovir: Infants 1 to <3 Months n = 7	Famciclovir: Infants 3 to <6 Months n = 5	Famciclovir: Infants 6 to 12 Months n = 5
Value	1.00 (1.00 to 5.17)	4 (1.00 to 4.17)	1.02 (0.58 to 1.10)

Population analysed: 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.

Primary outcome: Pharmacokinetics of Single Dose - Cmax

Time frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.. Mean (Standard Deviation). Unit: μg/mL

Measure	Famciclovir: Infants 1 to <3 Months n = 7	Famciclovir: Infants 3 to <6 Months n = 5	Famciclovir: Infants 6 to 12 Months n = 5
Value	0.69 (0.41)	0.74 (0.17)	3.24 (1.01)

Primary outcome: Pharmacokinetics of Single Dose - AUC(0-tlast)

Time frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.. Mean (Standard Deviation). Unit: (μg/mL)•h

Measure	Famciclovir: Infants 1 to <3 Months n = 7	Famciclovir: Infants 3 to <6 Months n = 5	Famciclovir: Infants 6 to 12 Months n = 5
Value	2.09 (1.38)	3.16 (0.68)	8.68 (2.09)

Primary outcome: Pharmacokinetics of Single Dose - AUC(0-6h)

Time frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.. Mean (Standard Deviation). Unit: (μg/mL)•h

Measure	Famciclovir: Infants 1 to <3 Months n = 7	Famciclovir: Infants 3 to <6 Months n = 5	Famciclovir: Infants 6 to 12 Months n = 5
Value	2.22 (1.23)	3.16 (0.68)	8.77 (2.14)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Famciclovir	1 of 18 (5.6%)	8 of 18 (44.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20160046Blumer 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.
Related InfoLink provided by the sponsor.

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
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
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Not yet recruitingPhase 2
Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
HSV-2 Infection

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 principal investigator

Novartis

Dr. Jeffery L. Blumer principal investigator

University Hospital Cased Medical Center Rainbow Babies and Children's Hospital, Cleveland, OH

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing famciclovir in people with Herpes Simplex, run by Novartis at 6 sites in United States.

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 1 inclusion and 2 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 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 Dec 2010). 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?

Pharmacokinetics of Single Dose - Tmax (time frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.). The study lists 4 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 NCT00448227, 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 11 Feb 2011.