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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03409627 | Novel INXN-4001 Triple Effector Plasmid in Heart Failure | PHASE1 | COMPLETED | 12 | — | — | Apr 9, 2018 | Aug 12, 2020 | Dec 4, 2020 | 2 | United States |
As assessed by incidence of all study intervention-related adverse events occurring up to 6 months post- treatment intervention-related adverse events
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Single infusion of INXN-4001, Dose 1 |
| Group 2 | EXPERIMENTAL | Single infusion of INXN-4001, Dose 2 |
| Name | Type | Description |
|---|---|---|
| INXN-4001 | BIOLOGICAL | Retrograde coronary sinus infusion of triple effector plasmid (INXN-4001) |
Inclusion Criteria: * Male and female adult patients with a stable LVAD implanted for end-stage heart failure * Must be managed in an outpatient setting and on stable medication regimen Exclusion Criteria: * Women who are pregnant or nursing * Patients who have been on another clinical trial for ...