Status:
COMPLETED
VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 wi...
Eligibility Criteria
Inclusion
- 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
- life-threatening CMV disease according to the investigator's judgment;
- pregnant or lactating women.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT00431353
Start Date
April 1 2004
End Date
August 1 2008
Last Update
November 2 2016
Active Locations (50)
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1
Chermside, Australia, 4032
2
Darlinghurst, Australia, 2010
3
Sydney, Australia, 2145
4
Woolloongabba, Australia, 4102