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A clinical study (Phase III) to assess the Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hemato...

Update Il y a 4 ans
Reference: EUCTR2013-000903-18

A clinical study (Phase III) to assess the Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT), when compared against placebo in a randomised, double blind manner

Woman and Man

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Extract

• 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 one year post-transplant. • To evaluate the safety of ASP0113 in subjects undergoing allogeneic HCT

Inclusion criteria

  • CMV reactivation after allogeneic stem cell transplantation

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