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CLINICAL TRIALS PROFILE FOR FAMCICLOVIR
Clinical Trials for Famciclovir
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT00098046 | Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection | Completed | Novartis | Phase 3 | 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. |
| NCT00098059 | Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection | Completed | Novartis Pharmaceuticals | Phase 3 | 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. |
| NCT00129818 | A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding | Completed | Novartis | Phase 4 | 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. |
| NCT00171990 | Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes | Completed | Novartis | Phase 3 | 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. |
| Trial ID | Title | Status | Sponsor | Phase | Summary |
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Clinical Trial Sponsors for Famciclovir
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