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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 is a Phase 3 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 5 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00275314
The ClinicalTrials.gov registry entry for NCT00275314 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Valganciclovir is the first listed.
NCT00275314 reports 0 study locations.
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.
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