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

Last updated: November 1, 2016
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

4

Condition

Cytomegalovirus Infections

Treatment

N/A

Clinical Study ID

NCT00431353
MV17973
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 contraceptionthroughout, and for 90 days after the end of the study.

Exclusion

Exclusion Criteria:

  • life-threatening CMV disease according to the investigator's judgment;

  • pregnant or lactating women.

Study Design

Total Participants: 325
Study Start date:
April 01, 2004
Estimated Completion Date:
August 31, 2008

Connect with a study center

  • Chermside, 4032
    Australia

    Site Not Available

  • Darlinghurst, 2010
    Australia

    Site Not Available

  • Sydney, 2145
    Australia

    Site Not Available

  • Woolloongabba, 4102
    Australia

    Site Not Available

  • Wien, 1090
    Austria

    Site Not Available

  • Bruxelles, 1070
    Belgium

    Site Not Available

  • Campinas, 13086-970
    Brazil

    Site Not Available

  • Porto Alegre, 90020-090
    Brazil

    Site Not Available

  • Sao Paulo, 05403-900
    Brazil

    Site Not Available

  • Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Toronto, Ontario M5G 1L7
    Canada

    Site Not Available

  • Zagreb, 10000
    Croatia

    Site Not Available

  • Tallinn, 10617
    Estonia

    Site Not Available

  • Tartu, 51014
    Estonia

    Site Not Available

  • Chennai, 600 004
    India

    Site Not Available

  • Lucknow, 226 014
    India

    Site Not Available

  • New Delhi, 110076
    India

    Site Not Available

  • Vellore, 632 004
    India

    Site Not Available

  • Dublin, 4
    Ireland

    Site Not Available

  • Coppito, 67100
    Italy

    Site Not Available

  • Padova, 35128
    Italy

    Site Not Available

  • Riga, LV-1002
    Latvia

    Site Not Available

  • Aguascalientes, 20230
    Mexico

    Site Not Available

  • Mexico City, 06720
    Mexico

    Site Not Available

  • Auckland, 1001
    New Zealand

    Site Not Available

  • Oslo,
    Norway

    Site Not Available

  • Bydgoszcz, 85-094
    Poland

    Site Not Available

  • Gdansk, 80-211
    Poland

    Site Not Available

  • Poznan, 60-479
    Poland

    Site Not Available

  • Warszawa, 02-006
    Poland

    Site Not Available

  • Wroclaw, 50-417
    Poland

    Site Not Available

  • Zabrze, 41-800
    Poland

    Site Not Available

  • Belgrade, 11000
    Serbia

    Site Not Available

  • Alicante, 03010
    Spain

    Site Not Available

  • Barakaldo, 48903
    Spain

    Site Not Available

  • Barcelona, 08907
    Spain

    Site Not Available

  • La Laguna,
    Spain

    Site Not Available

  • Madrid,
    Spain

    Site Not Available

  • Basel, 4031
    Switzerland

    Site Not Available

  • Antalya, 07000
    Turkey

    Site Not Available

  • Istanbul, 34126
    Turkey

    Site Not Available

  • Izmir, 35100
    Turkey

    Site Not Available

  • Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • Oxford, OX3 7LJ
    United Kingdom

    Site Not Available

  • Caracas, 1040
    Venezuela

    Site Not Available

  • Maracaibo, 4001
    Venezuela

    Site Not Available

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