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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01713361 | Active Comparator-Controlled Study to Assess Safety and Efficacy of ISIS-FXIRx in Total Knee Arthroplasty | PHASE2 | COMPLETED | 315 | — | — | Oct 1, 2012 | Aug 1, 2014 | Aug 27, 2014 | 21 | Bulgaria, Canada +3 |
Composite of asymptomatic DVT (via bilateral venography), and symptomatic VTE, fatal PE, and unexplained death.
| Arm | Type | Description |
|---|---|---|
| ISIS-FXIRx Dose 2 | EXPERIMENTAL | Group B: ISIS-FXIRx Dose #2 |
| ISIS-FXIRx Dose 3 | EXPERIMENTAL | Group C: ISIS-FXIRx Dose #3 |
| Enoxaparin | ACTIVE_COMPARATOR | Enoxaparin (40mg) |
| Name | Type | Description |
|---|---|---|
| ISIS-FXIRx Dose #2 | DRUG | Group B: ISIS-FXIRx dose #2 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery. |
| ISIS-FXIRx Dose #3 | DRUG | Group C: ISIS-FXIRx dose #3 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery. |
| Enoxaparin | DRUG | Enoxaparin (40mg) will be administered by subcutaneous injection the evening prior to total knee arthroplasty (optionally), 6 to 8 hours after surgery, followed by daily injections for at least 8 additional days post surgery (a total of at least 9 consecutive days). \[Except for Canadian region, in which the subcutaneous injection of enoxaparin the evening prior to total knee arthroplasty is expected, resulting in a total of at least 10 consecutive days of enoxaparin.\] |
Inclusion Criteria: * Give written informed consent * Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. Males must be surgically sterile, abstinent, or if engaged in sexual relations of child-bearing potential, must use contraception * Undergoing elec...