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 for hemostasis, meaning it is applied to help control bleeding during surgery. It is being developed as an adjunct to achieve hemostasis in surgical procedures, as evaluated in a clinical trial for patients undergoing surgery.
Human thrombin is being developed by Grifols, S.A., a biopharmaceutical company. Grifols is the sponsor of the clinical trial for this investigational product, which is being studied for its use in achieving hemostasis during surgery.
Human thrombin is in Phase 2 clinical development. It is an investigational product, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.
Human thrombin has been studied in one completed Phase 2 clinical 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.
Yes, Human thrombin is classified as a monoclonal antibody in terms of its modality. However, it is applied topically to promote hemostasis during surgery, and its mechanism of action involves the coagulation process.