Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01769170 | A Study of the Safety and Efficacy of CMX001 for the Prevention of CMV Infection in CMV-seropositive HCT Recipients | PHASE3 | COMPLETED | 452 | — | — | Aug 1, 2013 | Jan 1, 2016 | Jul 21, 2021 | 43 | United States, Belgium +1 |
Clinically significant cytomegalovirus (CMV) infection was defined by either of the following outcomes: 1. Onset of CMV end-organ disease; or 2. Initiation of anti-CMV-specific preemptive therapy based on documented CMV viremia (as measured by the central virology laboratory) and the clinical condition of the subject. CMV viremia (i.e., the measurement of CMV DNA in plasma) was determined by the designated central virology laboratory at all scheduled visits via quantitative polymerase chain reaction (qPCR) testing using the Roche COBAS® AmpliPrep/COBAS® TaqMan® CMV Test.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Matching placebo administered orally twice weekly |
| Brincidofovir | ACTIVE_COMPARATOR | 100 mg brincidofovir administered orally twice weekly |
| Name | Type | Description |
|---|---|---|
| Brincidofovir | DRUG | - |
| Placebo | OTHER | - |
Inclusion Criteria Subjects were required to meet all of the following criteria, as applicable, to be eligible to participate in this study: 1. Were allogeneic hematopoietic stem cell transplant (HCT) recipients who had prior evidence of cytomegalovirus (CMV) exposure (CMV-seropositive) before tra...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 7 | PHASE3 | Maribavir, LIVTENCITY |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1647 |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | Letermovir |