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NCT01877655 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 514
- Enrollment target
NCT01877655 is a Phase 3 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 514 participants.
The verdict
NCT01877655, a Phase 3 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 514 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- BIOLOGICAL ASP0113
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 514 participants |
| Start Date | 2013-09-11 |
| Est. Completion | 2022-03-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01877655
The ClinicalTrials.gov registry entry for NCT01877655 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 514 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01877655 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01877655 about?
NCT01877655 is a clinical study titled "A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)". 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.
What is the current status of trial NCT01877655?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 514 participants. The study started on 2013-09-11. Estimated completion is 2022-03-01.
What interventions are being tested in trial NCT01877655?
The interventions under investigation include: Placebo (DRUG), ASP0113 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01877655?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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