Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 is an investigational drug being studied for arterial occlusive diseases, acute ischemic stroke, and acute peripheral arterial occlusion. It is a monoclonal antibody developed by Grifols, S.A. Plasmin is currently in clinical development and is not approved by the FDA.
Plasmin is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential role in treating conditions involving arterial occlusion, such as acute ischemic stroke and peripheral arterial occlusion.
Plasmin is being developed by Grifols, S.A., a biopharmaceutical company. Grifols is publicly traded under the ticker symbol GRFS. The company is conducting clinical trials to evaluate Plasmin for the treatment of arterial occlusive diseases.
Plasmin is in Phase 1 clinical development. It has completed Phase 1 trials for arterial occlusive diseases and acute ischemic stroke, and a Phase 2 trial for acute peripheral arterial occlusion has also been completed. Plasmin remains investigational and is not yet approved.
Plasmin has been studied in three completed clinical trials. NCT00418483 was a Phase 1 dose escalation study in acute lower extremity artery occlusion. NCT01014975 was a Phase 1 safety study in acute ischemic stroke. NCT01222117 was a Phase 2 study in acute peripheral arterial occlusion.
Plasmin is distinct from plasminogen. Plasmin is the active enzyme that degrades fibrin clots, while plasminogen is its inactive precursor. In the context of this drug, Plasmin refers to the therapeutic agent being developed by Grifols for arterial occlusive conditions.