Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Amchafibrin · 1 trial · 1 indication
Total blood loss greater than 245 ml
| Arm | Type | Description |
|---|---|---|
| Amchafibrin | EXPERIMENTAL | Estimated total blood loss, measured using the formula described by Nadler. A difference in estimated blood loss greater than or equal to 245 ml will be considered clinically relevant. |
| Saline Solution 0,9%. | PLACEBO_COMPARATOR | Comparator of tranexamic acid |
| Name | Type | Description |
|---|---|---|
| Amchafibrin | DRUG | Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin. |
| Saline Solution | OTHER | Placebo |
Inclusion Criteria: * Patients of both sexes, in the age group: ≥18 and ≤80 years. * Patients diagnosed with confirmation of severe knee osteoarthritis according to Kellgren criteria (equal or greater than 2) and EVA greater than 7, who will be subjected to knee arthroplasty surgery. * Patients sig...
Amchafibrin is an investigational small molecule being studied for use in osteoarthritis of the knee. It is being evaluated for its efficacy and safety in reducing blood loss during prosthetic knee surgery in patients with this condition. The drug is currently in Phase 3 clinical development.
Amchafibrin targets the fibrinolytic system to reduce blood loss. It is a small molecule that works by inhibiting fibrinolysis, the process that breaks down blood clots, thereby helping to maintain clot stability and reduce bleeding during surgical procedures.
Amchafibrin is being developed by Design Therapeutics, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol DSGN. Design Therapeutics is responsible for the clinical development and regulatory strategy for this investigational drug.
Amchafibrin is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions for the treatment of osteoarthritis of the knee.
Amchafibrin has been studied in one completed Phase 3 clinical trial with the identifier NCT03386656. This randomized, double-blind, placebo-controlled trial enrolled 150 participants with osteoarthritis of the knee in Spain. The study evaluated the efficacy and safety of topical application of Amchafibrin for saving blood loss during prosthetic knee surgery.
Amchafibrin is the same as tranexamic acid. The clinical trial NCT03386656 evaluated the topical application of tranexamic acid, which is the active ingredient in Amchafibrin. This antifibrinolytic agent is used to reduce blood loss during surgery in patients with osteoarthritis of the knee.