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

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Open-label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

325

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Chermside, Australia, 4032
      • Darlinghurst, Australia, 2010
      • Sydney, Australia, 2145
      • Woolloongabba, Australia, 4102
  • Austria
      • Wien, Austria, 1090
  • Belgium
      • Bruxelles, Belgium, 1070
  • Brazil
      • Campinas, Brazil, 13086-970
      • Porto Alegre, Brazil, 90020-090
      • Sao Paulo, Brazil, 05403-900
      • Sao Paulo, Brazil, 01323-900
      • Sao Paulo, Brazil, 04038-002
      • Sao Paulo, Brazil, 05651-901
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • Ontario
      • Toronto, Ontario, Canada, M5G 1L7
  • Croatia
      • Zagreb, Croatia, 10000
  • Estonia
      • Tallinn, Estonia, 10617
      • Tartu, Estonia, 51014
  • India
      • Chennai, India, 600 004
      • Lucknow, India, 226 014
      • New Delhi, India, 110076
      • Vellore, India, 632 004
  • Ireland
      • Dublin, Ireland, 4
  • Italy
      • Coppito, Italy, 67100
      • Padova, Italy, 35128
  • Latvia
      • Riga, Latvia, LV-1002
  • Mexico
      • Aguascalientes, Mexico, 20230
      • Mexico City, Mexico, 06720
  • New Zealand
      • Auckland, New Zealand, 1001
  • Norway
      • Oslo, Norway
  • Poland
      • Bydgoszcz, Poland, 85-094
      • Gdansk, Poland, 80-211
      • Poznan, Poland, 60-479
      • Warszawa, Poland, 02-006
      • Wroclaw, Poland, 50-417
      • Zabrze, Poland, 41-800
  • Serbia
      • Belgrade, Serbia, 11000
  • Spain
      • Alicante, Spain, 03010
      • Barakaldo, Spain, 48903
      • Barcelona, Spain, 08907
      • La Laguna, Spain
      • Madrid, Spain
  • Switzerland
      • Basel, Switzerland, 4031
  • Turkey
      • Antalya, Turkey, 07000
      • Istanbul, Turkey, 34662
      • Istanbul, Turkey, 34126
      • Izmir, Turkey, 35100
  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
      • Oxford, United Kingdom, OX3 7LJ
  • Venezuela
      • Caracas, Venezuela, 1040
      • Maracaibo, Venezuela, 4001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients >=18 years of age;
  • recipients of solid organ(s) transplant;
  • virologic and clinical evidence of CMV disease after transplantation;
  • patients of childbearing potential must be prepared to use effective contraception throughout, and for 90 days after the end of the study.

Exclusion Criteria:

  • life-threatening CMV disease according to the investigator's judgment;
  • pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: valganciclovir [Valcyte]
900mg po bid for 21 days
Experimental: 2
Drug: Ganciclovir
5mg/kg iv bid for 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment success (CMV viremia BLQ)
Time Frame: Day 21
Day 21

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to eradication of CMV viremia, percentage of patients with resolution of symptoms, percentage of patients with eradication of CMV viremia, time to CMV viremia recurrence, effect on HHV-6, HHV-7 and EBV viremia.
Time Frame: Throughout study
Throughout study
AEs, laboratory parameters, appearance of ganciclovir resistance.
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

February 2, 2007

First Submitted That Met QC Criteria

February 2, 2007

First Posted (Estimate)

February 5, 2007

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MV17973

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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