Phase 3
N=136
Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation
Cytomegalovirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT00227370 ↗Enrolled (actual)
136
Serious AEs
53.7%
Results posted
Apr 2013
Primary outcome: Primary: Incidence of CMV End Organ Disease — 21; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- valganciclovir (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of CMV End Organ Disease |
21; 1 | — |
| PRIMARY Incidence of CMV Syndrome |
13; 0 | — |
| SECONDARY Any CMV Infection |
42; 7 | — |
| SECONDARY Biopsy Proven Acute Lung Rejection |
22; 15 | — |
| SECONDARY Non-CMV Infection |
35; 38 | — |
| SECONDARY Severity of Viremia |
110,000; 3,200 | — |
| SECONDARY Ganciclovir Resistance |
1; 2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00227370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.