Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SOLX (Investigational)
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 small molecule additive solution developed by Haemonetics Corporation for use with donated whole blood. It is studied in combination with CPD anticoagulant as an AS-7/SOLX additive solution intended for blood donors. SOLX is also referred to as SOLX (Investigational).
SOLX is being evaluated as an additive solution for whole blood collected from donors, used alongside CPD anticoagulant. The research focuses on processing and storing donated whole blood. It is an investigational product and is not described as approved for any use.
SOLX is developed by Haemonetics Corporation, which trades under the ticker HAE. The company is the sponsor behind the clinical evaluation of the AS-7/SOLX additive solution for donated whole blood.
SOLX is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. SOLX remains an investigational product and is not described as FDA approved.
SOLX has been studied in one completed Phase 1 trial, NCT02145507, titled Evaluation of Whole Blood With CPD Anticoagulant and AS-7/SOLX Additive Solution. The trial enrolled 170 participants in the United States, was controlled and randomized, and included healthy volunteers aged 18 years and older.
Yes, SOLX (Investigational) is an alternative name for SOLX, the additive solution developed by Haemonetics Corporation. Both names refer to the same Phase 1 asset studied with CPD anticoagulant for donated whole blood.