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

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.

Study Overview

• Status: Completed
• Conditions: Acute Anemia
• Intervention / Treatment: Drug: SANGUINATE™

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Brookwood Princeton Baptist
  • Arizona
    • Prescott, Arizona, United States, 86301
      • Yavapai Regional Medical Center
  • California
    • Baldwin Park, California, United States, 91706
      • Kaiser Permanente
    • Duarte, California, United States, 91010
      • City of Hope
    • Lancaster, California, United States, 93534
      • Antelope Valley Hospital
    • Loma Linda, California, United States, 92354
      • Loma Linda Medical Center
    • Mission Hills, California, United States, 91345
      • Providence Holy Cross Hospital
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20007
      • Medstar Georgetown University Hosiptal
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
    • Marietta, Georgia, United States, 30066
      • Wellstar Atlanta Medical Centre
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Detroit Medical Center Harper Univesity Hospital
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Medical Center
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Livingston, New Jersey, United States, 07039
      • St. Barnabas
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell - North Shore University Hospital
    • New York, New York, United States, 10029
      • Mt. Sinai /Recanati/Miller Transplantation Institute, Icahn
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Presbyterian Hospital Novant Health
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington University
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19106
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19106
      • Hahnemann University Hospital (Rittenhouse)
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29607
      • Bon Secour St Francis Cancer Center
  • Texas
    • El Paso, Texas, United States, 79905
      • University of Texas Medical Center (El Paso)
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77030
      • St. Lukes
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53214
      • Blood Center of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SANGUINATE™; As Needed Dosing of SANGUINATE	Drug: SANGUINATE™; As needed (PRN) infusions of 500 mL of SANGUINATE; Other Names: pegylated carboxyhemoglobin bovine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of serious adverse events following the start of SANGUINATE infusions through the final visit (up to 28 days)	Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, death and other reported serious adverse events	28 Days

Collaborators and Investigators

• Sponsor: Prolong Pharmaceuticals
• Investigators: Study Director: Abe Abuchowski, PhD, Prolong Pharamceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): May 17, 2017
• Study Completion (Actual): May 17, 2017

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: SGHY-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No