Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FS Grifols · 1 trial · 1 indication
The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved.
| Arm | Type | Description |
|---|---|---|
| FS Grifols Preliminary Part (I) | EXPERIMENTAL | Open label administration of FS Grifols to all subjects |
| FS Grifols Primary Part (II) | EXPERIMENTAL | Single-blind, randomized (2:1) |
| Manual Compression Primary Part (II) | ACTIVE_COMPARATOR | Single-blind, randomized (2:1) |
| Name | Type | Description |
|---|---|---|
| FS Grifols | BIOLOGICAL | Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I) |
| Manual Compression | PROCEDURE | Manual Compression. Primary Part (II) |
Inclusion Criteria: * Are male or female * Must be at least 3 years of age with no upper age limit (must be at least 18 years of age in Spain and United Kingdom) * Require an elective (non-emergency), open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure * Have hemoglobin...
FS Grifols is a fibrin sealant used as an adjunct to hemostasis to control bleeding at the target bleeding site during peripheral vascular surgery. It is a monoclonal antibody modality being developed by Grifols, S.A. for this surgical indication.
FS Grifols is being developed by Grifols, S.A., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GRFS. The company is conducting clinical research on this fibrin sealant for use in peripheral vascular surgery.
FS Grifols is in Phase 2 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 2 trial has been completed to evaluate its safety and efficacy as an adjunct to hemostasis.
FS Grifols has one completed Phase 2 clinical trial, registered as NCT00684047, titled "Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis." The trial enrolled 239 participants across Canada, Spain, and the United Kingdom.
Yes, FS Grifols is the same as fibrin sealant Grifols. The clinical trial NCT00684047 refers to the product as "Fibrin Sealant Grifols," and FS Grifols is the name used for this fibrin sealant product in development.