Drugs / ASP0113
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02103426 | Dec 2013 → May 2016 | cytomegalovirus infection | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT01974206 | Nov 2013 → May 2016 | — | Astellas Pharma Global Development, Inc. | Completed | Missed primary |
| Phase 2 | NCT01903928 | Jun 2013 → Jan 2015 | disease related to hematopoietic stem cell transplant | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT01877655 | Sep 2013 → Sep 2017 | cytomegalovirus infection, disease related to hematopoietic stem cell transplant | Astellas Pharma Global Development, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2018-01-22 | Astellas Pharma Inc | Results Astellas and Vical Announce Top-Line Results for Phase 3 Trial of Cytomegalovirus Vaccine ASP0113 in Hematopoietic Stem Cell Transplant Recipients astellas.com ↗
Efficacy was assessed using a primary composite endpoint of overall mortality and CMV end-organ disease through the first year following the transplant, an endpoint which was not met. |
| 2016-09-19 | Astellas Pharma Inc | Results Vical and Astellas Announce Topline Results from a Phase 2 Study of Investigational Cytomegalovirus (CMV) Vaccine (ASP0113) in Kidney Transplant Patients astellas.com ↗
Additionally, the secondary endpoints of CMV-associated disease and CMV-specific antiviral therapy, which were evaluated by an independent, blinded Adjudication Committee, were similar in both treatment groups. |
All press releases naming this drug 3 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ASP0113 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02103426 ↗ |
| Modality | Vaccine | “ASP0113, a DNA-based vaccine” PMID 33842870 ↗ Mar 2021 |
| Route | Intramuscular | “Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection” NCT01877655 ↗ |