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NCT00090766 · ClinicalTrials.gov registry record · Phase 2

A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients

A Phase 2 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
63
Enrollment target

NCT00090766: Completed Phase 2 study, sponsored by Hoffmann-La Roche.

NCT00090766 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00090766, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
63 participants
Enrollment target

Study Summary

This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.

Primary Outcome

Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24 hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to measure the plasma concentrations of valganciclovir. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.

Interventions

  • DRUG valganciclovir [Valcyte]

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2004-05
Est. Completion 2005-05
Phase Phase 2
Hoffmann-La Roche

909 total trials

What the finished NCT00090766 record still lists

NCT00090766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 1 intervention - of which valganciclovir [Valcyte] is the first listed.

NCT00090766 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00090766 about?

NCT00090766 is a clinical study titled "A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients". This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.

What is the current status of trial NCT00090766?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2004-05. Estimated completion is 2005-05.

What interventions are being tested in trial NCT00090766?

The interventions under investigation include: valganciclovir [Valcyte] (DRUG).

Who is sponsoring clinical trial NCT00090766?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00090766's enrollment target sits among peer trials

63 1009th of 2000 higher than 985 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00090766, the US trial registry maintained by the National Library of Medicine. NCT00090766 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.