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

• Status: Completed
• Trial end date: 2017-05-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prolong Pharmaceuticals

Criteria

Inclusion Criteria:

1. The patient would otherwise receive RBC transfusion for treatment of severe anemia but cannot (hemolytic/allosensitized or no compatible blood) or will not (religious/personal objection) receive RBCs

2. Hemoglobin ≤ 5 g/dL, or hemoglobin ≤ 7 g/dL following a decline of ≥ 5 g/dL over less than 7 days

3. Age ≥ 18 years

4. Receiving or willing to receive supplemental iron therapy (unless contraindicated)

5. Receiving or willing to receive erythropoiesis-stimulating agent (EPO) therapy

6. Patient or legally authorized representative provided consent to participate

7. Investigator determination that the patient is an appropriate candidate for study enrollment

Exclusion Criteria:

1. Hemoglobin ≤ 2 g/dL

2. Presence of severe trauma (e.g., Injury Severity Score (ISS)/New Injury Severity Score (NISS) Score ≥ 25)

3. Unable to provide sufficient blood sample volume for screening assessments; or

4. Pregnant; or

5. Investigator determination that the patient is not an appropriate candidate for study enrollment