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

NCT02754999 | Completed Phase 1

• 1 other identifier: SGHY-001
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 32

Brief 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.

Conditions

Acute Anemia

Outcome Measures

Primary Outcomes (1)

• Number and severity of adverse events within 24-hours of each SANGUINATE infusion

  Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, death and other reported adverse events

  24 Hours

Secondary Outcomes (6)

• Percentage of patients who survive the acute episode of severe anemia

  14 Days

• Percentage of patients who recover from hypoxia-induced abnormal end-organ function

  14 Days

• Percentage of patients who improved with their hemodynamic status

  14 Days

• Percentage of patients who discontinue inotrope therapy

  14 Days

• Percentage of patients who discontinue respiratory support/therapy

  14 Days

Study Arms (1)

SANGUINATE™

EXPERIMENTAL

As Needed Dosing of SANGUINATE

Drug: SANGUINATE™

Interventions

SANGUINATE™ DRUG

As needed (PRN) infusions of 500 mL of SANGUINATE

Also known as: pegylated carboxyhemoglobin bovine

SANGUINATE™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Prolong Pharmaceuticals: lead

Study Sites (32)

Brookwood Princeton Baptist

Birmingham, Alabama, 35213, United States

Location

Yavapai Regional Medical Center

Prescott, Arizona, 86301, United States

Location

Kaiser Permanente

Baldwin Park, California, 91706, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Antelope Valley Hospital

Lancaster, California, 93534, United States

Location

Loma Linda Medical Center

Loma Linda, California, 92354, United States

Location

Providence Holy Cross Hospital

Mission Hills, California, 91345, United States

Location

Medstar Georgetown University Hosiptal

Washington D.C., District of Columbia, 20007, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Wellstar Atlanta Medical Centre

Marietta, Georgia, 30066, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Detroit Medical Center Harper Univesity Hospital

Detroit, Michigan, 48201, United States

Location

Englewood Medical Center

Englewood, New Jersey, 07631, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

St. Barnabas

Livingston, New Jersey, 07039, United States

Location

Northwell - North Shore University Hospital

Lake Success, New York, 11042, United States

Location

Mt. Sinai /Recanati/Miller Transplantation Institute, Icahn

New York, New York, 10029, United States

Location

Presbyterian Hospital Novant Health

Charlotte, North Carolina, 28204, United States

Location

Abington University

Abington, Pennsylvania, 19001, United States

Location

Hahnemann University Hospital (Rittenhouse)

Philadelphia, Pennsylvania, 19106, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19106, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Bon Secour St Francis Cancer Center

Greenville, South Carolina, 29607, United States

Location

University of Texas Medical Center (El Paso)

El Paso, Texas, 79905, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

St. Lukes

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Blood Center of Wisconsin

Milwaukee, Wisconsin, 53214, United States

Location

MeSH Terms

Interventions

PEGylated carboxyhemoglobin bovine

Study Officials

• Abe Abuchowski, PhD

  Prolong Pharamceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: April 28, 2016
• Study Start: March 1, 2016
• Primary Completion: May 17, 2017
• Study Completion: May 17, 2017
• Last Updated: June 27, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)