The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.
Participants will be followed for 5.5 years post-transplant for long-term safety via an annual telephone contact.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
514
Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant
This was the composite of all-cause mortality and adjudicated CMV EOD through 1 year posttransplant, The CMV EOD was assessed by the independent and blinded adjudication committee, which counted events that were observed up to day 380 from transplantation. Deaths that occurred up to day 365 from transplant were also counted.
Time frame: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Percentage of Participants With Protocol-Defined CMV Viremia Through 1 Year Posttransplant
Protocol-defined CMV viremia was defined as a CMV plasma viral load ≥1000 IU/mL as assessed by the central laboratory. Rate was based on cumulative incidence function estimated at 1 year. The central laboratory had the lower limit of quantification \[LLOQ\] for CMV viral load assessment, so when the viral load was below the LLOQ the actual viral load reading was not possible and was denoted as ≤LLOQ. If participant had any CMV viral load assessments greater than the LLOQ it was classified as viremic.
Time frame: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Percentage of Participants With Adjudicated CMV-Specific Antiviral Therapy (AVT) Through 1 Year Posttransplant
The CMV-specific AVT use was adjudicated by the independent and blinded committee. When the CMV-specific AVT was initiated, a central CMV viral load was obtained weekly until it was discontinued. Participants without any CMV-specific AVT events were censored on the last study evaluation.
Time frame: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Percentage of Participants With a Composite Endpoint of Protocol-defined CMV Viremia and Adjudicated CMV-Specific AVT Use
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Site US10028
Birmingham, Alabama, United States
Site US10044
Tucson, Arizona, United States
Site US10035
San Francisco, California, United States
Site US10026
Stanford, California, United States
Site US10030
Tampa, Florida, United States
Site US10012
Atlanta, Georgia, United States
Site US10013
Chicago, Illinois, United States
Site US10007
Indianapolis, Indiana, United States
Site US10020
Westwood, Kansas, United States
Site US10010
Louisville, Kentucky, United States
...and 73 more locations
Protocol-defined CMV viremia was as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. The CMV-specific AVT was determined by the adjudication committee. Participants with no posttransplant viral load data were excluded from the analysis.
Time frame: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Percentage of Participants With First Occurrence of Adjudicated CMV-specific AVT or Adjudicated Diagnosis of CMV EOD After Study Drug First Injection Through 1 Year Posttransplant
Rate was based on cumulative incidence function estimate at 1 year. Time to first CMV-specific AVT was defined as time to the start of AVT for CMV viremia or CMV EOD. CMV-specific AVT and EOD were determined by the adjudication committee. This endpoint was a composite endpoint based on the independent adjudication committee assessments of CMV-specific AVT and CMV EOD.
Time frame: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
All-Cause Mortality at 1 Year Posttransplant
All-cause mortality through 1-year post-transplantation summary included all deaths and unknown survival status. For the known deaths, the adjudication committee assessed results and summarized them according to the following category: Mortality due to the participant's primary disease, and mortality due to causes unrelated to the participant's primary disease. Participants with unknown survival status at 1 year were considered dead for this analysis.
Time frame: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)