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

Completed · Phase 1

Conditions studied: Acute Anemia

In brief

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.

Key facts

Study ID

NCT02754999

Run by

Prolong Pharmaceuticals

People needed

103

Starts

2016-03-01

Expected to finish

2017-05-17

Last updated by the study team

2017-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Hemoglobin ≤ 5 g/dL, or hemoglobin ≤ 7 g/dL following a decline of ≥ 5 g/dL over less than 7 days
• Age ≥ 18 years
• Receiving or willing to receive supplemental iron therapy (unless contraindicated)
• Receiving or willing to receive erythropoiesis-stimulating agent (EPO) therapy
• Patient or legally authorized representative provided consent to participate
• Investigator determination that the patient is an appropriate candidate for study enrollment

You may not qualify if…

• Hemoglobin ≤ 2 g/dL
• Presence of severe trauma (e.g., Injury Severity Score (ISS)/New Injury Severity Score (NISS) Score ≥ 25)
• Unable to provide sufficient blood sample volume for screening assessments; or
• Pregnant; or
• Investigator determination that the patient is not an appropriate candidate for study enrollment

Where it is running

• Brookwood Princeton Baptist — Birmingham, Alabama, United States
• Yavapai Regional Medical Center — Prescott, Arizona, United States
• Kaiser Permanente — Baldwin Park, California, United States
• City of Hope — Duarte, California, United States
• Antelope Valley Hospital — Lancaster, California, United States
• Loma Linda Medical Center — Loma Linda, California, United States
• Providence Holy Cross Hospital — Mission Hills, California, United States
• Medstar Georgetown University Hosiptal — Washington D.C., District of Columbia, United States
• Tampa General Hospital — Tampa, Florida, United States
• Augusta University — Augusta, Georgia, United States
• Wellstar Atlanta Medical Centre — Marietta, Georgia, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Detroit Medical Center Harper Univesity Hospital — Detroit, Michigan, United States
• Englewood Medical Center — Englewood, New Jersey, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• St. Barnabas — Livingston, New Jersey, United States
• Northwell - North Shore University Hospital — Lake Success, New York, United States
• Mt. Sinai /Recanati/Miller Transplantation Institute, Icahn — New York, New York, United States
• Presbyterian Hospital Novant Health — Charlotte, North Carolina, United States
• Abington University — Abington, Pennsylvania, United States
• Hahnemann University Hospital (Rittenhouse) — Philadelphia, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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