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CompletedNCT00431353Updated Nov 2, 2016

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

A Phase 4 interventional study of Ganciclovir and valganciclovir [Valcyte] in Cytomegalovirus Infections, sponsored by Hoffmann-La Roche. Completed at 50 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
325
Allocation
Randomized
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Cytomegalovirus Infections
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In context

Cytomegalovirus Infections

359 studies on the registry are indexed under Cytomegalovirus Infections; 59 are open to participants now.

This study's enrollment of 325 is above the median of 60 across 233 interventional studies indexed under Cytomegalovirus Infections.

Browse Cytomegalovirus Infections studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
325 participants (actual)

Study arms

  • Experimental
    1

    Drug: valganciclovir [Valcyte]

  • Experimental
    2

    Drug: Ganciclovir

Interventions

  • DrugGanciclovir

    5mg/kg iv bid for 21 days

  • Drugvalganciclovir [Valcyte]

    900mg po bid for 21 days

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What researchers measure

Primary outcomes

  1. Incidence of treatment success (CMV viremia BLQ)

    Time frame: Day 21

Secondary outcomes

  1. 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

  2. AEs, laboratory parameters, appearance of ganciclovir resistance.

    Time frame: Throughout study

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Study locations

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

Publications

  • Ueland T, Rollag H, Hartmann A, Jardine A, Humar A, Bignamini AA, Asberg A, Aukrust P. Increased osteoprotegerin predicts poor virological outcome during anticytomegalovirus therapy in solid organ transplant recipients. Transplantation. 2015 Jan;99(1):100-5. doi: 10.1097/TP.0000000000000227. PubMed 24983306 ↗
  • Ueland T, Rollag H, Hartmann A, Jardine AG, Humar A, Michelsen AE, Bignamini AA, Asberg A, Aukrust P. Secreted Wnt antagonists during eradication of cytomegalovirus infection in solid organ transplant recipients. Am J Transplant. 2014 Jan;14(1):210-5. doi: 10.1111/ajt.12506. Epub 2013 Nov 13. PubMed 24224707 ↗
  • Rollag H, Ueland T, Asberg A, Hartmann A, Jardine AG, Humar A, Pescovitz MD, Bignamini AA, Aukrust P. Characterization of cytomegalovirus disease in solid organ transplant recipients by markers of inflammation in plasma. PLoS One. 2013 Apr 8;8(4):e60767. doi: 10.1371/journal.pone.0060767. Print 2013. PubMed 23593305 ↗
  • Razonable RR, Asberg A, Rollag H, Duncan J, Boisvert D, Yao JD, Caliendo AM, Humar A, Do TD. Virologic suppression measured by a cytomegalovirus (CMV) DNA test calibrated to the World Health Organization international standard is predictive of CMV disease resolution in transplant recipients. Clin Infect Dis. 2013 Jun;56(11):1546-53. doi: 10.1093/cid/cit096. Epub 2013 Feb 15. PubMed 23418272 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00431353
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Feb 5, 2007
Start date
Apr 2004
Primary completion
Aug 2008
Completion
Aug 2008
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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