A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/30/2018 |
Start Date: | November 20, 2013 |
End Date: | November 2020 |
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
The purpose of this study is to evaluate the efficacy of ASP0113 compared to placebo in
reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects
receiving a kidney from a CMV-seropositive donor. This study will also evaluate the safety of
ASP0113 in this patient population.
reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects
receiving a kidney from a CMV-seropositive donor. This study will also evaluate the safety of
ASP0113 in this patient population.
Subjects will be followed for one year after first study drug injection. This is the primary
study period.
Subjects will be followed for 4.5 years after completion of the primary study to assess
long-term safety of the vaccine.
study period.
Subjects will be followed for 4.5 years after completion of the primary study to assess
long-term safety of the vaccine.
Inclusion Criteria:
- CMV negative subject having received a CMV seropositive kidney (living or deceased)
- Subject started valganciclovir or ganciclovir within 10 days of transplant and has
received it through Randomization.
Exclusion Criteria:
- Subject is planned to undergo a course of CMV-specific prophylactic therapy with
antiviral drugs with a duration of greater than 100 days.
- Subject has received from one month prior to transplant or is planning to receive CMV
immunoglobulin.
- Subject has had CMV viremia or CMV disease from time of transplant until time of
Randomization.
We found this trial at
30
sites
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