Status:
COMPLETED
Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients
Lead Sponsor:
Salvador Gil-Vernet
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Cytomegalovirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objectives of this study were: 1. To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV infection/disease in SOT patients (kidney, liver and heart recipients) bas...
Detailed Description
SOT recipients (kidney, liver and heart transplant) presenting CMV infection or disease were eligible for inclusion if they were ≥18 years of age and presented a positive CMV antigenemia (pp65) define...
Eligibility Criteria
Inclusion
- ≥18 years of age, solid organ transplant recipients.
- presented a CMV infection demonstrated by CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC).
- gave written informed consent.
Exclusion
- HIV patients.
- Multiorganic transplant.
- Severe CMV tissue invasive disease.
- Unable to receive oral medication.
- absolute neutrophil counts less than 500/ mm3.
- Platelets \<25000 platelets/mm3.
- Hemoglobin\< 80g/l.
- Estimated glomerular filtration rate\< 10 mL/min (according to the Cockcroft-Gault formula)
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00730769
Start Date
March 1 2004
End Date
July 1 2008
Last Update
September 21 2011
Active Locations (1)
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1
Hospital Universitari Bellvitge- Transplant Departments (Liver, Heart and Kidney)
L'Hospitalet de Llobregat, Barcelone, Spain, 08907