NCT01877655

A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 514 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be followed for 5.5 years post-transplant for long-term safety via an annual telephone contact.

Conditions

• Cytomegalovirus (CMV)-Positive Recipients
• Allogeneic, Hematopoietic Cell Transplant (HCT)

Interventions

Type	Name	Description
BIOLOGICAL	ASP0113	Intramuscular injection
DRUG	Placebo	Intramuscular injection

Timeline

• Start date: 2013-09-11
• Primary completion: 2017-09-28
• Completion: 2022-03-01
• First posted: 2013-06-14
• Last updated: 2024-10-24
• Results posted: 2018-11-28

Locations

83 sites across 11 countries: United States, Australia, Belgium, Canada, France, Germany, Japan, South Korea, Spain, Sweden, Taiwan