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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00431353 |
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.
Condition | Intervention | Phase |
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Cytomegalovirus Infections |
Drug: valganciclovir [Valcyte] Drug: Ganciclovir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients |
Enrollment: | 325 |
Study Completion Date: | August 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: valganciclovir [Valcyte]
900mg po bid for 21 days
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2: Experimental |
Drug: Ganciclovir
5mg/kg iv bid for 21 days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | MV17973 |
Study First Received: | February 2, 2007 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00431353 History of Changes |
Health Authority: | Norway: Norwegian Medicines Agency |
Virus Diseases Valganciclovir Cytomegalic Inclusion Disease Cytomegalovirus Infections Ganciclovir |
DNA Virus Infections Viremia Antiviral Agents Cytomegalovirus Herpesviridae Infections |
Virus Diseases Anti-Infective Agents Valganciclovir Therapeutic Uses Cytomegalovirus Infections Ganciclovir |
DNA Virus Infections Infection Antiviral Agents Pharmacologic Actions Herpesviridae Infections |