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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

NCT00275314 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2015-12-17

No results posted yet for this 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.

Conditions

  • Kidney Transplant

Interventions

DRUG

Valganciclovir

Sponsors & Collaborators

Principal Investigators

  • David L Paterson, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Completion
2006-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00275314 on ClinicalTrials.gov