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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00090766 |
This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.
Condition | Intervention | Phase |
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Cytomegalovirus Infections |
Drug: valganciclovir [Valcyte] |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | An Open-Label Study of the Safety and Pharmacokinetics of Valcyte Syrup in Pediatric Solid Organ Transplant Patients |
Enrollment: | 63 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: valganciclovir [Valcyte]
po daily (dose based on body surface area and CrCL)
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Ages Eligible for Study: | 3 Months to 16 Years |
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: | WV16726 |
Study First Received: | September 3, 2004 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00090766 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Valganciclovir Cytomegalovirus Infections DNA Virus Infections |
Cytomegalic inclusion disease Cytomegalovirus Herpesviridae Infections |
Anti-Infective Agents Therapeutic Uses Infection Antiviral Agents Pharmacologic Actions |