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NCT00098059 · ClinicalTrials.gov registry record · Phase 3
Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 74
- Enrollment target
NCT00098059: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00098059 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 74 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00098059, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 74 participants
- Enrollment target
Study 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.
Primary Outcome
A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.
Interventions
- DRUG Famciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2005-02 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
What the finished NCT00098059 record still lists
NCT00098059 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Famciclovir is the first listed.
NCT00098059 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00098059 about?
NCT00098059 is a clinical study titled "Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection". 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 famci...
What is the current status of trial NCT00098059?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 74 participants. The study started on 2005-02. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00098059?
The interventions under investigation include: Famciclovir (DRUG).
Who is sponsoring clinical trial NCT00098059?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00098059's enrollment target sits among peer trials
74 1780th of 2000 higher than 221 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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