drugset / Trial / NCT02754999

A Phase 1 Safety Study of SANGUINATE™ In Patients With Acute Severe Anemia.

NCT02754999

Phase 1 Completed 103 enrolled Prolong Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

In this open-label study, eligible and consenting adult patients admitted to the hospital for critical care that have acute severe anemia, defined as a blood hemoglobin level ≤ 5 g/dL, but who are unwilling or unable to receive red blood cell (RBC) transfusion, will receive one or more infusions of SANGUINATE as are deemed necessary by the Investigator for survival of the acute anemic episode.

Timeline

Start
2016-03
Primary completion
2017-05-17
Completion
2017-05-17

Drugs

EvaluationDrugModalityDoseRoute
Subject pegylated carboxyhemoglobin bovine Protein / enzyme biologic 500 ml

Indications