Approval Probability
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Mirasol-treated Fresh Whole Blood · 1 trial · 1 indication
New case of any pre-defined TTIs (HIV, HBV, HCV, HEV, HHV-8, malaria, and/or bacterial infection) in a previously negative patient and matched from the blood donor, indicated by changes in laboratory findings at Day 2, Day 7, Week 4, or Week 10 after the first transfusion.
| Arm | Type | Description |
|---|---|---|
| Mirasol-treated Fresh Whole Blood | EXPERIMENTAL | Standard Fresh Whole Blood, treated with Mirasol Pathogen Reduction Technology |
| Standard Fresh Whole Blood | PLACEBO_COMPARATOR | Standard-issue fresh whole blood |
| Name | Type | Description |
|---|---|---|
| Mirasol-treated Fresh Whole Blood | BIOLOGICAL | Standard issue FWB, which gave negative serological assay results for HIV, HBV, HCV, and syphilis will subsequently be treated with Mirasol PRT, then stored at 1 - 6 degrees Celsius and transfused within 21 days of collection. |
| Standard Fresh Whole Blood | BIOLOGICAL | Fresh whole blood that gave negative serological assay results for HIV, HBV, HCV, and syphilis will be stored at 1 - 6 degrees Celsius and transfused within 21 days of collection. |
Inclusion Criteria: * Willing to participate in study and patient or legally authorized representative has given written informed consent (IC) * Hemoglobin \< 7 g/dL or decision to transfusion by clinical team * Transfusion necessary based on clinical judgment of attending physician * Agree to retu...
Mirasol-treated Fresh Whole Blood is an investigational blood product being studied for the reduction of transfusion-transmitted infectious disease. It is developed by United Therapeutics Corporation (UTHR) and is currently in Phase 3 clinical development. The product is intended to reduce the risk of infections transmitted through blood transfusions.
Mirasol-treated Fresh Whole Blood is a pathogen reduction technology that uses riboflavin and ultraviolet light to inactivate pathogens in whole blood. It targets a broad range of infectious agents, including viruses, bacteria, and parasites, to reduce the risk of transfusion-transmitted infections. The technology is designed to be applied to whole blood before transfusion.
Mirasol-treated Fresh Whole Blood is being developed by United Therapeutics Corporation, a biotechnology company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the safety and efficacy of this blood product for reducing transfusion-transmitted infections.
Mirasol-treated Fresh Whole Blood is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. The Phase 3 trial, known as the Mirasol Evaluation of Reduction in Infections Trial (NCT03737669), has been completed, with enrollment of 2,000 participants.
Mirasol-treated Fresh Whole Blood has one completed Phase 3 clinical trial, NCT03737669, titled 'Mirasol Evaluation of Reduction in Infections Trial.' This randomized, double-blind, placebo-controlled study enrolled 2,000 participants in Uganda to evaluate the product's effect on transfusion-transmitted infectious disease. The trial has been completed.
Mirasol-treated Fresh Whole Blood refers to whole blood that has been treated with the Mirasol pathogen reduction technology system. This system uses riboflavin and ultraviolet light to inactivate pathogens. The product is being developed by United Therapeutics Corporation and is currently in Phase 3 clinical trials for reducing transfusion-transmitted infections.