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

Primary Purpose

Acute Anemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SANGUINATE™
Sponsored by
Prolong Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brookwood Princeton Baptist
  • Yavapai Regional Medical Center
  • Kaiser Permanente
  • City of Hope
  • Antelope Valley Hospital
  • Loma Linda Medical Center
  • Providence Holy Cross Hospital
  • Medstar Georgetown University Hosiptal
  • Tampa General Hospital
  • Augusta University
  • Wellstar Atlanta Medical Centre
  • Johns Hopkins University
  • Detroit Medical Center Harper Univesity Hospital
  • Englewood Medical Center
  • Hackensack University Medical Center
  • St. Barnabas
  • Northwell - North Shore University Hospital
  • Mt. Sinai /Recanati/Miller Transplantation Institute, Icahn
  • Presbyterian Hospital Novant Health
  • Abington University
  • Hahnemann University Hospital (Rittenhouse)
  • University of Pennsylvania
  • Thomas Jefferson University
  • University of Pittsburgh
  • Medical University of South Carolina
  • Bon Secour St Francis Cancer Center
  • University of Texas Medical Center (El Paso)
  • Houston Methodist Hospital
  • St. Lukes
  • Virginia Commonwealth University
  • Swedish Medical Center
  • Blood Center of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SANGUINATE™

Arm Description

As Needed Dosing of SANGUINATE

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of patients who survive the acute episode of severe anemia
Percentage of patients who recover from hypoxia-induced abnormal end-organ function
Percentage of patients who improved with their hemodynamic status
Percentage of patients who discontinue inotrope therapy
Percentage of patients who discontinue respiratory support/therapy
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

Full Information

First Posted
April 26, 2016
Last Updated
June 26, 2017
Sponsor
Prolong Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02754999
Brief Title
A Phase 1 Safety Study of SANGUINATE™ In Patients With Acute Severe Anemia.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 17, 2017 (Actual)
Study Completion Date
May 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prolong Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SANGUINATE™
Arm Type
Experimental
Arm Description
As Needed Dosing of SANGUINATE
Intervention Type
Drug
Intervention Name(s)
SANGUINATE™
Other Intervention Name(s)
pegylated carboxyhemoglobin bovine
Intervention Description
As needed (PRN) infusions of 500 mL of SANGUINATE
Primary Outcome Measure Information:
Title
Number and severity of adverse events within 24-hours of each SANGUINATE infusion
Description
Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, death and other reported adverse events
Time Frame
24 Hours
Secondary Outcome Measure Information:
Title
Percentage of patients who survive the acute episode of severe anemia
Time Frame
14 Days
Title
Percentage of patients who recover from hypoxia-induced abnormal end-organ function
Time Frame
14 Days
Title
Percentage of patients who improved with their hemodynamic status
Time Frame
14 Days
Title
Percentage of patients who discontinue inotrope therapy
Time Frame
14 Days
Title
Percentage of patients who discontinue respiratory support/therapy
Time Frame
14 Days
Title
Number of serious adverse events following the start of SANGUINATE infusions through the final visit (up to 28 days)
Description
Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, death and other reported serious adverse events
Time Frame
28 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abe Abuchowski, PhD
Organizational Affiliation
Prolong Pharamceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Brookwood Princeton Baptist
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Yavapai Regional Medical Center
City
Prescott
State/Province
Arizona
ZIP/Postal Code
86301
Country
United States
Facility Name
Kaiser Permanente
City
Baldwin Park
State/Province
California
ZIP/Postal Code
91706
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Antelope Valley Hospital
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Loma Linda Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Providence Holy Cross Hospital
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Medstar Georgetown University Hosiptal
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Wellstar Atlanta Medical Centre
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Detroit Medical Center Harper Univesity Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Englewood Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
St. Barnabas
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Northwell - North Shore University Hospital
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Mt. Sinai /Recanati/Miller Transplantation Institute, Icahn
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Presbyterian Hospital Novant Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Abington University
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Hahnemann University Hospital (Rittenhouse)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Bon Secour St Francis Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
University of Texas Medical Center (El Paso)
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Lukes
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Blood Center of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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