Status:
COMPLETED
Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation
Lead Sponsor:
Duke University
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ini...
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 p...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Phase I:
- Adult lung transplant recipients age 18 or older
- At risk for CMV (donor or recipient serology must be positive for CMV)
- Adequate hematological and renal function,
- On intravenous (IV) ganciclovir within 24 hours of surgery
- Agreement to use effective methods of contraception
- Negative pregnancy
- Tolerate oral medications within 2 weeks of transplant
- Negative baseline CMV PCR
- Able to understand and sign the informed consent
- Exclusion Criteria for Phase 1:
- Repeat transplantation
- Mechanical ventilation at study entry
- Oral or intravenous ganciclovir treatment outside the study protocol
- Invasive fungal infection
- Participation in another investigational study
- Acute CMV infection or disease
- Anti-CMV therapy within 30 days before enrollment
- Uncontrolled diarrhea or malabsorption
- Allergic reaction to study drug
- Required use of prohibited medications
- Lactating women
- Pregnancy
- Renal failure
- Inclusion Criteria for Phase II:
- Negative serial post transplant PCRs at day 75
- Negative bronchial cultures for CMV
- Adequate hematological and renal function at day 75
- IV ganciclovir for up to 2 weeks post operation and open label up to day 90
- Effective contraceptives
- Negative pregnancy
- Exclusion Criteria Phase II:
- Renal failure
- Serious adverse events (SAE) related to study drug
- CMV disease (study endpoint)
- Withdraw consent for Phase II
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00227370
Start Date
July 1 2003
End Date
December 1 2008
Last Update
October 4 2024
Active Locations (1)
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1
DukeUMC
Durham, North Carolina, United States, 27710