A Phase 1 Safety Study of SANGUINATE™ In Patients With Acute Severe Anemia.
NCT ID: NCT02754999
Last Updated: 2017-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
103 participants
INTERVENTIONAL
2016-03-31
2017-05-17
Brief Summary
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Detailed Description
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A minimum of 100 subjects are to be enrolled and to receive at least one infusion of SANGUINATE, with 14-day follow-up after the last infusion.
Because of the life-threatening effects of severe anemia, it is expected that all patients in this trial will receive care within a critical care facility (may be called intensive care or some similar name), wherein all patients will have real-time monitoring of vital signs and ECG (e.g., by telemetry) before, during, and after all study drug infusions.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SANGUINATE™
As Needed Dosing of SANGUINATE
SANGUINATE™
As needed (PRN) infusions of 500 mL of SANGUINATE
Interventions
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SANGUINATE™
As needed (PRN) infusions of 500 mL of SANGUINATE
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Prolong Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Abe Abuchowski, PhD
Role: STUDY_DIRECTOR
Prolong Pharamceuticals
Locations
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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
Bon Secour St Francis Cancer Center
Greenville, South Carolina, United States
University of Texas Medical Center (El Paso)
El Paso, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
St. Lukes
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Blood Center of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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SGHY-001
Identifier Type: -
Identifier Source: org_study_id
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