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

Sponsors

Lead Sponsor: Prolong Pharmaceuticals

Source Prolong Pharmaceuticals
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.

Overall Status Completed
Start Date March 2016
Completion Date May 17, 2017
Primary Completion Date May 17, 2017
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Number and severity of adverse events within 24-hours of each SANGUINATE infusion 24 Hours
Secondary Outcome
Measure 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) 28 Days
Enrollment 103
Condition
Intervention

Intervention Type: Drug

Intervention Name: SANGUINATE™

Description: As needed (PRN) infusions of 500 mL of SANGUINATE

Arm Group Label: SANGUINATE™

Other Name: pegylated carboxyhemoglobin bovine

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

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

United States

Verification Date

May 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: SANGUINATE™

Type: Experimental

Description: As Needed Dosing of SANGUINATE

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov