Status:
TERMINATED
Trial of Preemptive Treatment With Oral Valganciclovir Compared With Intravenous (IV) Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant
Lead Sponsor:
Washington University School of Medicine
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to determine if preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing cytomegalovirus (CMV) viremia as determined by quantitat...
Detailed Description
* To study the effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR. * To determine the incidence of CMV disease and CMV related mortality follo...
Eligibility Criteria
Inclusion
- Patients receiving allogeneic peripheral blood stem cell transplant from either a related or unrelated donor at Washington University Medical Center.
- An initial episode of CMV viremia.
- At the time of randomization:
- ANC greater than or equal to 1000
- Age greater than or equal to 18
- Adequate renal function with creatinine clearance greater than 10 ml/min
- Total bilirubin less than or equal to 3.0
Exclusion
- Current GI graft versus host disease grade III-IV
- Development of CMV disease prior to or at the time of the first detection of CMV viremia by PCR
- Uncontrolled emesis or diarrhea (greater than or equal to 4 episodes per day) for 2 consecutive days
- Pregnant or nursing female patient
- Known hypersensitivity to ganciclovir
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00241345
Start Date
June 1 2004
End Date
December 1 2007
Last Update
July 23 2013
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110