Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Plasmin (Human)
Plasmin · 3 trials · 3 indications
The proportion of subjects with \>50% thrombolysis at the end of treatment compared to baseline by arteriography.
Thrombolysis at the end of treatment compared to baseline by arteriography
| Arm | Type | Description |
|---|---|---|
| Plasmin Open-label Treatment Group A | EXPERIMENTAL | Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate. |
| Plasmin Open-label Treatment Group B | EXPERIMENTAL | Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate |
| Plasmin Open-label Treatment Group C | EXPERIMENTAL | Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate. |
| Plasmin Open-label Treatment Group D | EXPERIMENTAL | Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate |
| Plasminogen Activator Blinded Group E | ACTIVE_COMPARATOR | PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice |
| PA Placebo Blinded Treatment Arm F | PLACEBO_COMPARATOR | PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration |
| Plasmin Open-label Treatment Group G | EXPERIMENTAL | Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate |
| Plasmin Open-label Treatment Group H | EXPERIMENTAL | Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate |
| Plasmin Open-label Treatment Group I | EXPERIMENTAL | Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter |
| Plasmin Open-label Treatment Group J | EXPERIMENTAL | Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter |
| Plasmin Open-label Treatment Group M | EXPERIMENTAL | Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter |
| 20 mg Plasmin (Human) | EXPERIMENTAL | 20 mg of Plasmin (Human) |
| 40 mg Plasmin (Human) | EXPERIMENTAL | 40 mg of Plasmin (Human) |
| 80 mg Plasmin (Human) | EXPERIMENTAL | 80 mg of Plasmin (Human) |
| Plasmin (Human) 25 mg | EXPERIMENTAL | Plasmin (Human) 25 mg |
| Plasmin (Human) 50 mg | EXPERIMENTAL | Plasmin (Human ) 50 mg |
| Plasmin (Human) 75 mg | EXPERIMENTAL | Plasmin (Human) 75 mg |
| Plasmin (Human) 100 mg | EXPERIMENTAL | Plasmin (Human) 100 mg |
| Plasmin (Human) 125 mg | EXPERIMENTAL | Plasmin (Human) 125 mg |
| Plasmin (Human) 150 mg | EXPERIMENTAL | Plasmin (Human) 150 mg |
| Plasmin (Human) 175 mg | EXPERIMENTAL | Plasmin (Human) 175 mg |
| Name | Type | Description |
|---|---|---|
| Plasmin | BIOLOGICAL | Plasmin prepared in 0.9% saline for injection |
| Plasminogen Activator | BIOLOGICAL | Plasminogen activator used according to the Investigator's clinical judgment. |
| Placebo | OTHER | Normal saline for injection at the same volume as the plasminogen activator. |
| Plasmin (Human) | BIOLOGICAL | Plasmin (Human), 20 mg, delivered through a catheter into a thrombus |
| Plasmin (Human) 25 mg | BIOLOGICAL | Plasmin (Human) 25 mg delivered via an infusion catheter into the thrombus over approximately 5 hours. |
| Plasmin (Human) 50 mg | BIOLOGICAL | Plasmin (Human) 50 mg delivered via an infusion catheter into the thrombus over approximately 5 hours. |
| Plasmin (Human) 75 mg | BIOLOGICAL | Plasmin (Human) 75 mg delivered via an infusion catheter into the thrombus over approximately 5 hours. |
| Plasmin (Human) 100 mg | BIOLOGICAL | Plasmin (Human) 100 mg |
| Plasmin (Human) 125 mg | BIOLOGICAL | Plasmin (Human) 125 mg delivered via an infusion catheter into the thrombus over approximately 5 hours. |
| Plasmin (Human) 150 mg | BIOLOGICAL | Plasmin (Human) 150 mg delivered via an infusion catheter into the thrombus over approximately 5 hours. |
| Plasmin (Human) 175 mg | BIOLOGICAL | Plasmin (Human) 175 mg delivered via an infusion catheter into the thrombus over approximately 5 hours. |
Inclusion Criteria: * Unilateral limb ischemia - Society of Vascular Surgery Categories I and IIa * Onset of symptoms less than or equal to 14 days * Thrombosed infrainguinal bypass graft or native artery * Diagnosis by arteriography of occlusive thrombus in graft or artery * Ability to embed the i...
Plasmin (Human) is being developed to treat acute ischemic stroke, acute peripheral arterial occlusion, and other arterial occlusive diseases. It is intended to be delivered directly into blood clots to restore blood flow. It remains investigational and has not been approved for commercial use.
Plasmin (Human) targets fibrinogen alpha, beta, and gamma chains, encoded by the FGA, FGB, and FGG genes. It is a hydrolytic enzyme that acts on fibrin, the structural protein that holds blood clots together, to break down the clot.
Plasmin (Human) is being developed by Grifols, S.A., which trades under the ticker GRFS. Grifols is a global healthcare company focused on plasma-derived medicines and transfusion diagnostics.
Plasmin (Human) is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA or any other regulatory agency. The program has completed one Phase 1 trial and one Phase 2 trial to date.
Plasmin (Human) has been studied in three completed trials: NCT01222117 in acute peripheral arterial occlusion, NCT01014975 in acute ischemic stroke, and NCT00418483 in arterial occlusive diseases. These trials enrolled 174, 40, and 83 patients respectively across multiple countries.