Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Human thrombin · 1 trial · 1 indication
Subjects achieving hemostasis at the target bleeding site by 5 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure
| Arm | Type | Description |
|---|---|---|
| IG1202-A (Vascular) | EXPERIMENTAL | - |
| IG1202-B (Hepatic) | EXPERIMENTAL | - |
| IG1202-C (Soft Tissue) | EXPERIMENTAL | - |
| IG1202-D (Spinal) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Human thrombin | BIOLOGICAL | Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges |
| Bovine thrombin | BIOLOGICAL | Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges |
Inclusion Criteria: * Pre-operative (at Baseline Assessments Visit) hemoglobin (Hgb) ≥9.0 g/dL (deciliter) * Pre-operative (at Baseline Assessments Visit) fibrinogen level ≥150 mg/dL (functional method). * Required one of the following procedures: 1. An elective (non-emergency), open (non-laparo...
Human thrombin is used as a topical hemostatic agent to help control bleeding during surgery. It is applied as an adjunct to hemostasis, meaning it supports the body's natural clotting process at the surgical site. Grifols is developing it for use in hemostasis within the hematology therapeutic area.
Human thrombin acts as an agonist at the insulin receptor, or INSR. As a monoclonal antibody directed at this target, it is designed to engage INSR as part of its mechanism. This agonist activity at the insulin receptor is the defined molecular target for the agent.
Human thrombin is developed by Grifols, S.A., which trades under the ticker GRFS. Grifols is the sponsor behind the clinical development of this topical hemostatic product for use during surgery.
Human thrombin is in Phase 2 clinical development. It is an investigational agent and is not approved, with one completed Phase 2 trial conducted to date. No active trials are currently listed for this asset.
Human thrombin has been studied in the completed Phase 2 trial NCT02014402, titled Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery. The trial enrolled 181 participants in the United States and was randomized, double-blind, and controlled.
Human thrombin is a distinct product derived from human sources, developed by Grifols, S.A. under the ticker GRFS. It should not be confused with recombinant thrombin products, which are manufactured through recombinant technology rather than sourced from human plasma.