At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 514 enrolled
Drug / intervention
ASP0113 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
In Brief
A Phase 3 clinical trial evaluating ASP0113 and Placebo for Cytomegalovirus (CMV)-Positive Recipients and Allogeneic, Hematopoietic Cell Transplant (HCT). Completed, enrolled 514 participants across 83 sites in 11 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytomegalovirus (CMV)-Positive Recipients, Allogeneic, Hematopoietic Cell Transplant (HCT)
CountriesAustralia, Belgium, Canada, France, Germany, Japan, South Korea, Spain, Sweden, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 2013
Enrollment StartSep 2013
Primary CompletionSep 2017
Study CompletionMar 2022
TodayJul 2026
First PostedJun 14, 2013
Enrollment StartSep 11, 2013
Primary CompletionSep 28, 2017
Study CompletionMar 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 13.0 years ago
Interventions
ASP0113biological
Intramuscular injection
Placebodrug
Intramuscular injection