Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ISIS-FXIRx Dose #2 · 1 trial · 1 indication
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...
ISIS-FXIRx Dose #2 is an investigational small molecule being developed for venous thromboembolism, a condition involving blood clots in the veins. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
ISIS-FXIRx Dose #2 is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
ISIS-FXIRx Dose #2 is in Phase 2 clinical development. It is an investigational drug and has not been approved for any use. One Phase 2 trial has been completed, and the drug is not currently in active clinical trials.
ISIS-FXIRx Dose #2 has one completed Phase 2 trial, NCT01713361, titled "Active Comparator-Controlled Study to Assess Safety and Efficacy of ISIS-FXIRx in Total Knee Arthroplasty." The trial enrolled 315 participants with venous thromboembolism across Bulgaria, Canada, Latvia, Russia, and Ukraine.
ISIS-FXIRx Dose #2 is a specific dose of the investigational drug ISIS-FXIRx. The clinical trial NCT01713361 evaluated the safety and efficacy of ISIS-FXIRx, including this dose, in patients undergoing total knee arthroplasty for venous thromboembolism prevention.