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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02268526 | Efficacy and Safety Study of CSJ148 in Stem Cell Transplant Patients | PHASE2 | COMPLETED | 86 | — | — | Jun 2, 2015 | Dec 7, 2016 | Jan 5, 2021 | 17 | United States, Belgium +4 |
Number of participants who require preemptive HCMV therapy. The definition of requiring preemptive anti-HCMV therapy was meeting either one of the following conditions: 1. the plasma HCMV DNA level is \>= 1000 copies/mL (with or without HCMV disease) or 2. the plasma HCMV DNA level is \< 1000 copies/mL, but HCMV disease was reported
Number of participants with adverse events as a measure of safety and tolerability. Patients treated with CSJ148 in Cohorts 1 and 2 were pooled to simplify the safety analyses.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: CSJ148 | EXPERIMENTAL | Cohort 1: CSJ148 IV q 4weeks |
| Cohort 2: CSJ148 | EXPERIMENTAL | Cohort 2: CSJ148 IV q 4weeks |
| Cohort 2: Placebo | PLACEBO_COMPARATOR | Cohort 2: Placebo IV q 4weeks |
| Name | Type | Description |
|---|---|---|
| CSJ148 | BIOLOGICAL | CSJ148 IV q 4weeks |
| Placebo | DRUG | Placebo IV q 4weeks |
Inclusion Criteria: Patients eligible for inclusion in this study had to fulfill all of the following criteria: 1. Written informed consent must be obtained before any assessment was performed. 2. Male and female patients at least 18 years of age. 3. Patients weighed between 45 -120 kg to particip...