Clinical Trials Logo
  1. Home
  2. Herpes Simplex
  3. NCT00098059

Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

Herpes Simplex Clinical Trial

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 After Administration of Famciclovir Oral Pediatric Formulation to Children 1 to 12 Years of Age With Herpes Simplex Infection

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00098059
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 3
Start date February 2005
Completion date December 2007
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05468619 - Neonatal Phase 1 Valacyclovir Study Phase 1
Withdrawn NCT02349828 - Antiviral Prophylaxis in a Burn Population Phase 2/Phase 3
Recruiting NCT01176409 - Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2? Phase 3
Completed NCT04664127 - Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection by Valacyclovir and Interferon Inducer Kagocel
Completed NCT00448227 - Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection Phase 2
Completed NCT00000139 - Herpetic Eye Disease Study (HEDS) II Phase 3
Completed NCT04239521 - The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
Completed NCT02209324 - Open-label Study of ASP2151 in Herpes Simplex Patients Phase 3
Completed NCT00855309 - Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia Phase 3
Completed NCT01602562 - Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients Phase 3
Completed NCT00973466 - Prevalence of Sexually Transmitted Infections (STIs) in HIV-infected Patients N/A
Completed NCT00698893 - Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults Phase 1
Active, not recruiting NCT05298254 - A Study on the Reactogenicity, Safety, Immune Response, and Efficacy of a Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes Phase 1/Phase 2
Recruiting NCT03178747 - Tzanck Smear With Methylene Blue Stain for Herpes Phase 3
Completed NCT00164424 - Episodic Acyclovir Therapy for Genital Ulcers Phase 2/Phase 3
Completed NCT00161434 - A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons Phase 4
Terminated NCT04762511 - A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years Phase 1
Completed NCT00699764 - Safety of a Herpes Simplex Candidate Vaccine (gD2t) With MPL and Its Efficacy to Prevent Genital Herpes Disease Phase 3
Recruiting NCT04065971 - Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections. Phase 4
Active, not recruiting NCT00005663 - A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients Phase 3