Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Completed
Novartis
Phase 3
2005-07-01
Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is
usually a self-limiting illness characterized by fever and a rash. Serious complications can
include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is
not a standard of care in immunocompetent children, but is recommended whenever a risk of
complication exists. This study will evaluate the safety and blood levels of a new
formulation of famciclovir in children 1-12 years of age.
Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
Completed
Novartis Pharmaceuticals
Phase 3
2005-02-01
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.
A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
Completed
Novartis
Phase 4
2004-07-01
The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day
(bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with
and without a reported history of genital herpes and with or without herpes virus type 1
(HSV-1) seropositivity.
Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Completed
Novartis
Phase 3
2003-01-01
This is a phase III, multicenter, randomized, double-blind, parallel-group study to compare
the efficacy and safety of a two-day treatment with famciclovir (500 mg loading dose followed
by 250 mg 12-hourly) to standard five-day treatment with famciclovir (125 mg 12-hourly) in
patients with active recurrent genital herpes.
This study is not recruiting patients in the United States.
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