Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
NCT00098046 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2007-09-26
Summary
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.
Conditions
- Chickenpox
- Herpes Zoster
Interventions
- DRUG
-
famciclovir
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-07-31
- Completion
- 2007-07-31
Countries
- United States
- Costa Rica
- Guatemala
- Panama
Study Locations
More Related Trials
-
A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster
NCT00900783 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
NCT00878072 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster
NCT01327144 ·Status: COMPLETED ·Phase: PHASE3
-
Palatability Testing of a New Paediatric Formulation of Valacyclovir
NCT01682109 ·Status: COMPLETED ·Phase: PHASE4
-
Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)
NCT01390857 ·Status: COMPLETED
-
A Study to Evaluate the Safety and Efficacy of Single Day or Single Dose Famciclovir for the Treatment of Recurrent Herpes Labialis
NCT00248144 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
NCT00129818 ·Status: COMPLETED ·Phase: PHASE4
-
Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth
NCT00031447 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
NCT00306787 ·Status: COMPLETED ·Phase: PHASE3
-
Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir
NCT01689285 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of Valacyclovir Oral Solution in Children
NCT04081480 ·Status: TERMINATED ·Phase: NA
-
RELIEF: Randomized Episodic Versus Long-Term Suppression Experience With Famciclovir
NCT00219310 ·Status: COMPLETED ·Phase: PHASE4
-
Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth
NCT00004757 ·Status: COMPLETED ·Phase: PHASE3
-
A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia
NCT02412917 ·Status: TERMINATED ·Phase: PHASE3
-
A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons
NCT00079911 ·Status: TERMINATED ·Phase: PHASE4
-
Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
NCT00171990 ·Status: COMPLETED ·Phase: PHASE3
-
Valaciclovir to Prevent Transmission of Herpes Simplex Virus
NCT00001649 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children
NCT00000837 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success With or Who Cannot Take Other Treatments for VZV
NCT00002358 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
NCT00005663 ·Status: UNKNOWN ·Phase: PHASE3
-
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
NCT00006132 ·Status: UNKNOWN ·Phase: PHASE3
-
Neonatal Phase 1 Valacyclovir Study
NCT05468619 ·Status: COMPLETED ·Phase: PHASE1
-
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
NCT00006135 ·Status: COMPLETED ·Phase: PHASE3
-
Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
NCT00477334 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluating New Formulation of Therapeutic HSV-2 Vaccine
NCT02515175 ·Status: COMPLETED ·Phase: PHASE2