Back to resultsVICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients
Primary Purpose
Cytomegalovirus Infections
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ganciclovir
valganciclovir [Valcyte]
Sponsored by
About this trial
This is an interventional treatment trial for Cytomegalovirus Infections
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Incidence of treatment success (CMV viremia BLQ)
Secondary Outcome Measures
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.
AEs, laboratory parameters, appearance of ganciclovir resistance.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00431353
Brief 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
Official Title
A Randomized, Open-label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
325 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ganciclovir
Intervention Description
5mg/kg iv bid for 21 days
Intervention Type
Drug
Intervention Name(s)
valganciclovir [Valcyte]
Intervention Description
900mg po bid for 21 days
Primary Outcome Measure Information:
Title
Incidence of treatment success (CMV viremia BLQ)
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
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
Title
AEs, laboratory parameters, appearance of ganciclovir resistance.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Chermside
ZIP/Postal Code
4032
Country
Australia
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
City
Sydney
ZIP/Postal Code
2145
Country
Australia
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
City
Campinas
ZIP/Postal Code
13086-970
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01323-900
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04038-002
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
05651-901
Country
Brazil
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1L7
Country
Canada
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
City
Chennai
ZIP/Postal Code
600 004
Country
India
City
Lucknow
ZIP/Postal Code
226 014
Country
India
City
New Delhi
ZIP/Postal Code
110076
Country
India
City
Vellore
ZIP/Postal Code
632 004
Country
India
City
Dublin
ZIP/Postal Code
4
Country
Ireland
City
Coppito
ZIP/Postal Code
67100
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
City
Mexico City
ZIP/Postal Code
06720
Country
Mexico
City
Auckland
ZIP/Postal Code
1001
Country
New Zealand
City
Oslo
Country
Norway
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
City
Poznan
ZIP/Postal Code
60-479
Country
Poland
City
Warszawa
ZIP/Postal Code
02-006
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-417
Country
Poland
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Alicante
ZIP/Postal Code
03010
Country
Spain
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
La Laguna
Country
Spain
City
Madrid
Country
Spain
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
City
Antalya
ZIP/Postal Code
07000
Country
Turkey
City
Istanbul
ZIP/Postal Code
34126
Country
Turkey
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
City
Caracas
ZIP/Postal Code
1040
Country
Venezuela
City
Maracaibo
ZIP/Postal Code
4001
Country
Venezuela
12. IPD Sharing Statement
Citations:
PubMed Identifier
24983306
Citation
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.
Results Reference
derived
PubMed Identifier
24224707
Citation
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.
Results Reference
derived
PubMed Identifier
23593305
Citation
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.
Results Reference
derived
PubMed Identifier
23418272
Citation
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.
Results Reference
derived
Learn more about this trial
VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients
We'll reach out to this number within 24 hrs