Trial information
VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients
Status: Completed
Protocol number: MV17973
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of oral Valcyte versus intravenous ganciclovir on CMV viremia in solid organ transplant patients
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.
Target sample size is 334.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Cytomegalovirus infections
Intervention type: Drug
Intervention name: valganciclovir [Valcyte]
Primary outcome: 1. Incidence of treatment success (CMV viremia BLQ) Time frame: Day 21
Key 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
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Austria
Belgium
Brazil
- Campinas
- Porto Alegre
- Sao Paulo
Canada
Croatia
Estonia
India
- Chennai
- Lucknow
- New Delhi
- Vellore
Italy
Latvia
Mexico
New Zealand
Norway
Poland
- Bydgoszcz
- Gdansk
- Poznan
- Warszawa
- Wroclaw
- Zabrze
Serbia and Montenegro
Spain
Switzerland
Turkey
United Kingdom
Venezuela
