Status:
COMPLETED
Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Bone Marrow Transplantation
Cytomegalovirus
Eligibility:
All Genders
14-70 years
Phase:
PHASE3
Brief Summary
The rationale for this protocol is based on the need to assess if the current post stem cell transplantation CMV prophylaxis strategies (e.g. high-dose acyclovir plus pre-emptive treatment) can be imp...
Detailed Description
Cytomegalovirus (CMV), the most common viral infection following stem cell transplantation (SCT), causes significant morbidity and mortality. It can result in CMV pneumonitis, hepatitis, encephalitis ...
Eligibility Criteria
Inclusion
- Undergoing allogeneic SCT from a matched related or unrelated donor without T cell depletion.
- Had an acceptable engraftment.
- Can take oral medications within 10 days of engraftment.
- Either the recipient or donor (or both) is CMV seropositive.
Exclusion
- Not fulfilling the inclusion criteria.
- History of CMV infection or disease.
- Anti-CMV therapy within the past 15 days.
- Severe, uncontrolled diarrhea.
- Both recipient and donor are CMV seronegative.
- Evidence of malabsorption.
- Inability to comply with study requirements.
- Known hypersensitivity or other contraindication to ganciclovir or valganciclovir.
- Pregnant or lactating patients.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00330018
Start Date
February 1 2006
End Date
April 1 2010
Last Update
April 21 2015
Active Locations (1)
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1
Hadassah Medical Organization,
Jerusalem, Israel, 91120