FindTrial
Sign In

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 <1 year of age with herpes simplex or varicella zoster virus infections

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 <1 year of age with herpes simplex or varicella zoster virus infections

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-005010-12-DE
Enrollment
18
Registered
2007-01-15
Start date
2007-04-02
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

herpes simplex or varicella zoster virus infections in infants 1 month to <1 year of age MedDRA version: 8.1 Level: LLT Classification code 10019948 Term: Herpes simplex

Interventions

Product Name: Famciclovir sprinkle capsules Product Code: FAM810B Pharmaceutical Form: Capsule, hard INN or Proposed INN: Famciclovir CAS Number: 104227-87-4 Current Sponsor code: FAM810 Concentratio

Sponsors

Novartis Pharma Services AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male and female patients from 1 month to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients with a gestational age 3% of calculated blood volume) in the past 30 days. 9. Patients who have taken an investigational drug or participated in an investigational study (with the exceptions of protocols studying marketed nucleoside analogues for herpes infections) within 30 days or 5 half-lives (which ever is longer) prior to study drug administration.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the pharmacokinetics of a single dose of famciclovir in infants 1 month to <1 year of age who are at risk of, or who have herpes simplex virus infections.;Secondary Objective: • To assess the safety of the single dose of famciclovir; and • To assess tolerability/acceptability of the pediatric formulation. ;Primary end point(s): Pharmacokinetics, safety and tolerability/acceptability—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026