Famciclovir Pediatric Formulation in Children 1-12 Years of Age With Herpes Simplex Infection
This study is currently recruiting patients
Verified by Novartis August 2006
| Sponsored by: |
Novartis |
| Information provided by: |
Novartis |
| ClinicalTrials.gov Identifier: |
NCT00098059 |
Purpose
Herpes simplex virus causes cold sores (fever blisters) and can lead to painful lesions in the mouth in healthy children. Children with impaired immune systems might develop severe complications. Famciclovir is a drug approved to treat herpes simplex and varicella zoster infection in adults. This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age.
| Condition |
Intervention |
Phase |
| Herpes Simplex |
Drug: Famvir (famciclovir) |
Phase III |
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety 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 Afer Administration of Famciclovir Oral Pediatric Formulation to Children 1 to 12 Years of Age With
Herpes Simplex Infection
Further study details as provided by Novartis:
Primary Outcomes: Step A: single-dose safety and pharmacokinetics; Step B: safety/tolerability of pediatric oral formulation administered 2 times daily over 7 days
Secondary Outcomes: Step A & B: acceptability of pediatric oral formulation by patients
Expected Total Enrollment:
76
Study start: February 2005
Eligibility
Ages Eligible for Study:
1 Year
-
12 Years,
Genders Eligible for Study:
Both
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: 1-862-778-5788 or 1-434-951-3228
Location
and Contact
Information
Please refer to this study by ClinicalTrials.gov identifier
NCT00098059
AlabamaUniversity of Alabama at Birmingham, Birmingham,
Alabama,
35233-1711,
United States; Recruiting
CaliforniaChildren’s Hospital of San Diego, San Diego,
California,
92123,
United States; Recruiting
ColoradoThe Children's Hospital, Denver,
Colorado,
80218,
United States; Recruiting
IllinoisChildren’s Memorial Hospital, Chicago,
Illinois,
60614,
United States; Recruiting
KentuckyKosair Charities Pediatric Clinical Research Unit, Louisville,
Kentucky,
40202-3830,
United States; Recruiting
New YorkState University of New York at, Stony Brook,
New York,
11794-3362,
United States; Recruiting
Columbia University Medical Center, New York,
New York,
10032,
United States; Recruiting
North CarolinaDuke University Medical Center, Durham,
North Carolina,
27710,
United States; Recruiting
OhioUniversity Hospitals of Cleveland, Cleveland,
Ohio,
44106,
United States; Recruiting
Cincinnati Children's Hospital Medical Center, Cincinnati,
Ohio,
45229-3039,
United States; Recruiting
TexasBaylor College of Medicine/Texas Children's Hospital, Houston,
Texas,
77030,
United States; Recruiting
Children's Medical Center of Dallas, Dallas,
Texas,
75235,
United States; Not yet recruiting
More Information
Study ID Numbers:
CFAM810B2303
Last Updated:
August 23, 2006
Record first received:
December 2, 2004
ClinicalTrials.gov Identifier:
NCT00098059Health Authority: United States: Food and Drug Administration ClinicalTrials.gov processed this record on 2006-10-02 |
