A Phase III, Randomized, Double-Blind Comparison of Oral Valganciclovir and Placebo for Prevention of CMV After Lung Transplantation
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Incidence of CMV End Organ Disease
Overview
Brief Summary
The study evaluated the efficacy and safety of a prolonged, continuous course of Valganciclovir (Valgan) in the prevention of CMV by comparing 3 months of Vaglanciclovir, the standard of care upon initiation of the study, to 12 months of Valganciclovir.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Valganciclovir 900 mg QD for 9 months post lung transplant.
Intervention: valganciclovir (Drug)
2
placebo for 9 months post lung transplant
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Incidence of CMV End Organ Disease
Time Frame: over the course of 300 days after randomization
The primary study end point was CMV end-organ disease determined by positive tissue immunostain or characteristic histopathology assessed for within 300 days post randomization.
Incidence of CMV Syndrome
Time Frame: over the course of 300 days after randomization
CMV clinical syndrome, with either positive serum PCR or positive culture for CMV from bronchoalveolar lavage and at least 2 of the following: fever, leukopenia, thrombocytopenia, elevated liver function test results malaise, reduction in pulmonary function (FEV1) greater than 20percent of baseline, or radiographic infiltrate consistent with CMV (all in the absence of other causes)
Secondary Outcomes
- Any CMV Infection(over the course of 300 days post randomization)
- Biopsy Proven Acute Lung Rejection(over the course of 300 days of randomization)
- Non-CMV Infection(over the course of 300 days after randomization)
- Severity of Viremia(over the course of 300 days after randomization)
- Ganciclovir Resistance(over the course of 300 days post randomization)