Trials / Completed
CompletedNCT00431353
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 Randomized, Open-label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 325 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ganciclovir | 5mg/kg iv bid for 21 days |
| DRUG | valganciclovir [Valcyte] | 900mg po bid for 21 days |
Timeline
- Start date
- 2004-04-01
- Primary completion
- 2008-08-01
- Completion
- 2008-08-01
- First posted
- 2007-02-05
- Last updated
- 2016-11-02
Locations
50 sites across 21 countries: Australia, Austria, Belgium, Brazil, Canada, Croatia, Estonia, India, Ireland, Italy, Latvia, Mexico, New Zealand, Norway, Poland, Serbia, Spain, Switzerland, Turkey (Türkiye), United Kingdom, Venezuela
Source: ClinicalTrials.gov record NCT00431353. Inclusion in this directory is not an endorsement.