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Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients

NCT00730769 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2011-09-21

No results posted yet for this study

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) based on 21 days of treatment.
2. To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with respect to ganciclovir given intravenously (i.v.).
3. Evaluate the security of this treatment with valganciclovir.

Conditions

  • Cytomegalovirus Infection

Interventions

DRUG

Single arm (ganciclovir and valganciclovir)

Patients received a short induction of IV ganciclovir at 5 mg/kg bid for 5 days (1 hour infusion) , followed by treatment with oral valganciclovir at 900 mg bid (after meals) for 16 days up to complet 21 days of treatment. In patients with impaired renal function, IV ganciclovir and oral valganciclovir doses were adjusted at each visit according to estimated GFR (Cockroft-Gault equation)

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Salvador Gil-Vernet

    lead OTHER

Principal Investigators

  • Salvador - Gil-Vernet, Medicine · Nephrology Department. Hospital Universitari of Bellvitge

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2007-07-31
Completion
2008-07-31

Countries

  • Spain

Study Locations

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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 NCT00730769 on ClinicalTrials.gov