Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection

This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex...

Date First Received: March 15, 2007

Last Updated: October 30, 2008

Verified by: Novartis, October 2008

Clinical Trial Phase: Phase 2 | Start Date: October 2007

Overall Status: Active, not recruiting

Estimated Enrollment: 18

Brief Summary

Official Title: “A Multicenter, Open-Label, Single-Arm Study to Evaluate the Single-Dose Pharmacokinetics, Acceptability and Safety of Famciclovir Oral Pediatric Formulation in Infants 1 Month to Less Than 1 Year of Age With Herpes Simplex Virus Infections”

Condition Keyword(s):

This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

  • Drug: famciclovir
    • oral; once a day; 100-200 mg depending on body weight
  • Drug: famciclovir
    • oral; once a day; 100-200 mg, depending body weight

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1

Outcome Measures for this Clinical Trial

Primary Measures

  • Pharmacokinetics of single dose
    • Time Frame: one day
      Safety Issue?: Yes

Secondary Measures

  • Safety assessed by AEs, SAEs and Labs
    • Time Frame: 38 days
      Safety Issue?: Yes
  • Tolerability and acceptability assessed by questionnaire
    • Time Frame: one day
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Male and female patients from 1 month up to 1 year of age Herpes simplex infection

Exclusion Criteria:

  • Patients with gestational age less than 32 weeks Patients unable to swallow Patients with history of malabsorption
  • Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Month

Maximum Age for this Clinical Trial: 1 Year

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Principal Investigator Novartis  

Additional Information

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00448227

Study ID Number: CFAM810B2301

ClinicalTrials.gov Identifier: NCT00448227

Health Authority: United States: Food and Drug Administration

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