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NCT00275314 · ClinicalTrials.gov registry record · Phase 3
WP16302 A Bioequivalence Study Comparing Ganciclovir From the Valganciclovir Syrup Formulation and the Commercial Valganciclovir 450mg Tablet (Valcyte®) at a Dose of 900mg in Kidney Transplant Recipients
A Phase 3 study, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- Phase 3
- Development phase
- 5
- Enrollment target
NCT00275314: Clinical Trial Phase 3 study, sponsored by University of Pittsburgh.
NCT00275314 is a Phase 3 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 5 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00275314, a Phase 3 study, was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 5 participants
- Enrollment target
Study Summary
This is a multi-center, open label, randomized, 3-way cross-over study. 21 subjects will be randomized to receive all three treatments in one of three treatment sequences. Patients at risk of CMV disease (D+R-, D+R+, D-R+), who are being treated prophylactically with Valcyte® (commercially available tablets), after their first or second kidney transplant and who have adequate renal and hematological function will be eligible for the study. Screening may be at any time after transplantation provided that follow-up procedures can be completed during the scheduled time of prophylaxis. The first dose of study drug may be between 1 and 14 days after screening provided the transplant has stabilized, stable serum creatinine and steady-state kinetics of ganciclovir and calcineurin inhibitor therapy have been attained. Follow-up will take place 7- 14 days after last dose of study drug administration; therefore the duration of the study will be up to 5 weeks.
Interventions
- DRUG Valganciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2006-02 |
| Est. Completion | 2006-04 |
| Phase | Phase 3 |
Why NCT00275314 stopped before completion
NCT00275314 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Valganciclovir is the first listed.
NCT00275314 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00275314 about?
NCT00275314 is a clinical study titled "WP16302 A Bioequivalence Study Comparing Ganciclovir From the Valganciclovir Syrup Formulation and the Commercial Valganciclovir 450mg Tablet (Valcyte®) at a Dose of 900mg in Kidney Transplant Recipients". This is a multi-center, open label, randomized, 3-way cross-over study. 21 subjects will be randomized to receive all three treatments in one of three treatment sequences. Patients at risk of CMV disease (D+R-, D+R+, D-R+), who are being treated prophylactically with Valcyte® (commercially availabl...
What is the current status of trial NCT00275314?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2006-02. Estimated completion is 2006-04.
What interventions are being tested in trial NCT00275314?
The interventions under investigation include: Valganciclovir (DRUG).
Who is sponsoring clinical trial NCT00275314?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00275314's enrollment target sits among peer trials
5 1997th of 2000 higher than 3 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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