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Sponsors and Collaborators: |
Duke University Hoffmann-La Roche |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00227370 |
The purpose of this study is to determine the rate of CMV at one year in the short course (Phase I of the study) as compared to extended prophylaxis in Phase II of the study.
Condition | Intervention | Phase |
---|---|---|
Cytomegalovirus Infections |
Drug: valganciclovir |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized, Double-Blind Comparison of Oral Valganciclovir and Placebo for Prevention of CMV After Lung Transplantation |
Estimated Enrollment: | 130 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | January 2008 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
900 mg QD
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Drug: valganciclovir
valgan and placebo 900mg QD
Drug: valganciclovir
anti-CMV
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2: Placebo Comparator
900 mg QD
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Drug: valganciclovir
anti-CMV
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A multi-center two phase, double-blind, placebo controlled, randomized prospective study of 130 lung transplant recipients. Patients will be screened and consented prior to transplant. All consented patients will receive IV ganciclovir within 24 hours of transplant for not more than 14 days. Patients will enroll in Phase I of the study is an open label safety and efficacy analysis of three months of oral valganciclovir in adult transplant recipients who are at risk for CMV. After completion of 3 months of open label therapy, patients that meet the criteria for Phase II of the study will be randomized to 9 months of blinded therapy (Placebo/Valgan). Phase II of the study is designed to assess the efficacy of short course sequential IV ganciclovir followed by oral valganciclovir as compared to the extended period of oral valganciclovir prophylaxis in the prevention of CMV disease in at risk lung transplant recipients
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for Phase I:
Exclusion Criteria for Phase 1:
Inclusion Criteria for Phase II:
Exclusion Criteria Phase II:
United States, North Carolina | |
DukeUMC | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Scott M Palmer, MD | Duke University |
Responsible Party: | Duke University Medical Center ( Scott Palmer, MD ) |
Study ID Numbers: | Val038 |
Study First Received: | September 26, 2005 |
Last Updated: | January 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00227370 |
Health Authority: | United States: Food and Drug Administration |
Acute rejection Non-CMV infections Resistance |
Virus Diseases Valganciclovir Cytomegalovirus Infections Ganciclovir |
DNA Virus Infections Cytomegalic inclusion disease Cytomegalovirus Herpesviridae Infections |
Anti-Infective Agents Therapeutic Uses Infection Antiviral Agents Pharmacologic Actions |