Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SOLX · 1 trial · 1 indication
The percent of recovered red blood cells when the content of pre-filtration whole blood is compared to the post-filtration leukoreduced whole blood content.
The level of residual white blood cells in whole blood filtered after either \<8 hours (AS-3) or 20-24hours (SOLX) of room temperature storage or cold storage for 72 hours.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Room Temperature Storage/Filtration | OTHER | SOLX (Investigational Product) and AS-3 (Control) |
| Arm 2 : Cold storage | OTHER | SOLX (Investigational Product) and AS-3 (Control) |
| Name | Type | Description |
|---|---|---|
| SOLX (Investigational) | DRUG | SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit. |
| AS-3 (Control) | DRUG | AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit |
Inclusion Criteria: * Age - Study donor must be ≥ 18 years of age * Weight - Study donor must be ≥ 110 pounds * Temperature - Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral) * Hemoglobin - Study donor's hemoglobin must be ≥12.5 g/dL * Hematocrit - Study donor's hematocrit must be ≥ ...
SOLX is an investigational additive solution used in the storage of whole blood collected from blood donors. It is being studied as part of a blood preservation system that includes CPD anticoagulant and the AS-7/SOLX additive solution, intended to maintain the quality of donated blood.
SOLX is being developed by Haemonetics Corporation, a company publicly traded under the ticker symbol HAE on the New York Stock Exchange. Haemonetics is conducting clinical research to evaluate the safety and effectiveness of SOLX in blood storage applications.
SOLX is in Phase 1 clinical development. A Phase 1 trial has been completed to evaluate the use of whole blood with CPD anticoagulant and the AS-7/SOLX additive solution. The drug is investigational and has not yet been approved by regulatory authorities.
SOLX has been studied in one clinical trial, registered as NCT02145507, titled 'Evaluation of Whole Blood With CPD Anticoagulant and AS-7/SOLX Additive Solution.' This Phase 1 trial was completed in the United States and enrolled 170 participants, all healthy blood donors.
SOLX is part of a combination product that includes the AS-7 additive solution. In the clinical trial, the additive solution is referred to as AS-7/SOLX, indicating that SOLX is the proprietary name for the AS-7 formulation being developed by Haemonetics for blood storage.