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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00431353




Registration number
NCT00431353
Ethics application status
Date submitted
2/02/2007
Date registered
5/02/2007
Date last updated
2/11/2016

Titles & IDs
Public title
VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients
Scientific title
A Randomized, Open-label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients
Secondary ID [1] 0 0
MV17973
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cytomegalovirus Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ganciclovir
Treatment: Drugs - valganciclovir [Valcyte]

Experimental: 1 -

Experimental: 2 -


Treatment: Drugs: Ganciclovir
5mg/kg iv bid for 21 days

Treatment: Drugs: valganciclovir [Valcyte]
900mg po bid for 21 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment success (CMV viremia BLQ)
Timepoint [1] 0 0
Day 21
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Throughout study
Secondary outcome [2] 0 0
AEs, laboratory parameters, appearance of ganciclovir resistance.
Timepoint [2] 0 0
Throughout study

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* life-threatening CMV disease according to the investigator's judgment;
* pregnant or lactating women.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2008
Sample size
Target
Accrual to date
Final
325
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Chermside
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- Sydney
Recruitment hospital [4] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2145 - Sydney
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Brazil
State/province [3] 0 0
Campinas
Country [4] 0 0
Brazil
State/province [4] 0 0
Porto Alegre
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Croatia
State/province [8] 0 0
Zagreb
Country [9] 0 0
Estonia
State/province [9] 0 0
Tallinn
Country [10] 0 0
Estonia
State/province [10] 0 0
Tartu
Country [11] 0 0
India
State/province [11] 0 0
Chennai
Country [12] 0 0
India
State/province [12] 0 0
Lucknow
Country [13] 0 0
India
State/province [13] 0 0
New Delhi
Country [14] 0 0
India
State/province [14] 0 0
Vellore
Country [15] 0 0
Ireland
State/province [15] 0 0
Dublin
Country [16] 0 0
Italy
State/province [16] 0 0
Coppito
Country [17] 0 0
Italy
State/province [17] 0 0
Padova
Country [18] 0 0
Latvia
State/province [18] 0 0
Riga
Country [19] 0 0
Mexico
State/province [19] 0 0
Aguascalientes
Country [20] 0 0
Mexico
State/province [20] 0 0
Mexico City
Country [21] 0 0
New Zealand
State/province [21] 0 0
Auckland
Country [22] 0 0
Norway
State/province [22] 0 0
Oslo
Country [23] 0 0
Poland
State/province [23] 0 0
Bydgoszcz
Country [24] 0 0
Poland
State/province [24] 0 0
Gdansk
Country [25] 0 0
Poland
State/province [25] 0 0
Poznan
Country [26] 0 0
Poland
State/province [26] 0 0
Warszawa
Country [27] 0 0
Poland
State/province [27] 0 0
Wroclaw
Country [28] 0 0
Poland
State/province [28] 0 0
Zabrze
Country [29] 0 0
Serbia
State/province [29] 0 0
Belgrade
Country [30] 0 0
Spain
State/province [30] 0 0
Alicante
Country [31] 0 0
Spain
State/province [31] 0 0
Barakaldo
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
La Laguna
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Switzerland
State/province [35] 0 0
Basel
Country [36] 0 0
Turkey
State/province [36] 0 0
Antalya
Country [37] 0 0
Turkey
State/province [37] 0 0
Istanbul
Country [38] 0 0
Turkey
State/province [38] 0 0
Izmir
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Liverpool
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Oxford
Country [41] 0 0
Venezuela
State/province [41] 0 0
Caracas
Country [42] 0 0
Venezuela
State/province [42] 0 0
Maracaibo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00431353
Trial related presentations / 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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00431353