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



Status:Completed
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:6/28/2017
Start Date:March 2016
End Date:May 17, 2017

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An Open-label Phase 1 Safety Study of SANGUINATE™ Infusion in Patients With Acute Severe Anemia Who Are Unable to Receive Red Blood Cell Transfusion

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.

Data collection for each patient during the in-patient portion of the study will be required
for up to a maximum of 14 days while under critical care, with additional collection of
safety-related findings at 7 days and 14 days after the last infusion of SANGUINATE. Each
patient will thus have up to 28 days participation in the trial.

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.

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
We found this trial at
32
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Loma Linda, California 92354
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Abington, Pennsylvania 19001
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Augusta, Georgia 30912
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1011 Baldwin Park Boulevard
Baldwin Park, California 91706
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200 Montgomery Highway
Birmingham, Alabama 35213
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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200 Hawthorne Lane
Charlotte, North Carolina 28204
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3990 John R Street
Detroit, Michigan 48201
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Duarte, California 91010
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4815 Alameda Avenue
El Paso, Texas 79905
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Englewood, New Jersey 07631
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104 Innovation Drive
Greenville, South Carolina 29607
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Houston, Texas 77030
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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450 Lakeville Road
Lake Success, New York 11042
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1600 W Avenue J
Lancaster, California 93534
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94 Old Short Hills Road
Livingston, New Jersey 07039
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805 Sandy Plains Road
Marietta, Georgia 30066
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Milwaukee, Wisconsin 53233
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15031 Rinaldi St
Mission Hills, California 91345
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1468 Madison Avenue
New York, New York 10029
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123 South Broad Street
Philadelphia, Pennsylvania 19106
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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1003 Willow Creek Road
Prescott, Arizona 86301
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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3800 Reservoir Road Northwest
Washington, D.C., District of Columbia 20007
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