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VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients

NCT00431353 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2016-11-02

No results posted yet for this study

Summary

This 2 arm study will evaluate the efficacy and safety of oral Valcyte compared with intravenous ganciclovir for the treatment of CMV disease in solid organ transplant recipients. Eligible patients will be randomized to receive either 1)Valcyte 900mg po bid or 2)ganciclovir 5mg/kg iv bid. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Conditions

  • Cytomegalovirus Infections

Interventions

DRUG

Ganciclovir

5mg/kg iv bid for 21 days

DRUG

valganciclovir [Valcyte]

900mg po bid for 21 days

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Croatia
  • Estonia
  • India
  • Ireland
  • Italy
  • Latvia
  • Mexico
  • New Zealand
  • Norway
  • Poland
  • Serbia
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom
  • Venezuela

Study Locations

More Related Trials

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 NCT00431353 on ClinicalTrials.gov