Official Title
An Expanded IND Access Investigation of HBOC-201 Infusion in Patients with Severe Acute Anemia Who Are Unable to Receive Red Blood Cell Transfusion
Brief Summary

HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, orreduce the need for red blood cell transfusions in anemic patientsThis is an expanded access IND protocol, and will provide treatment with HBOC-201 toseverely anemic adults for whom blood is not an option

Detailed Description

HBOC 201 [hemoglobin glutamer - 250 (bovine)] is an investigational agent, manufactured
by Hemoglobin Oxygen Therapeutics LLC (HbO2 Therapeutics), located in Souderton, PA.
HBOC-201, has been previously studied17-20 as an alternative to blood transfusions in
severely anemic patients needing a way to enhance tissue oxygenation. HBOC-201 is
purified, cross-linked and polymerized acellular bovine hemoglobin (Hb) in a modified
lactated Ringer's solution, and does not require blood compatibility.

HBOC-201 is an oxygen carrying fluid that increases plasma and total hemoglobin
concentration. HBOC-201 has a right-shifted oxygen binding equilibrium curve with a P50
of 40 ± 6 mmHg compared to 27 mmHg for corpuscular hemoglobin. When fully saturated,
HBOC-201 binds approximately 1.39 mL of oxygen per gram hemoglobin and, therefore, has
the same oxygen carrying capacity as whole blood having the same hemoglobin
concentration. To the extent that HBOC-201 administration increases the total hemoglobin
concentration in circulation, HBOC-201 is capable of increasing convective oxygen
delivery (DO2), defined as the product of blood oxygen content (ml O2/ml blood) and
volumetric blood flow (ml blood/min.) At concentrations corresponding to at least 10% of
the total hemoglobin concentration, HBOC-201 also facilitates diffusive oxygen delivery,
primarily by shortening diffusion distances between RBCs and between RBCs and the
endothelium. The higher P50 of HBOC-201 compared to that of cellular hemoglobin further
facilitates diffusion of oxygen from RBCs to tissues through increased oxygen
off-loading.

HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, or
reduce the need for red blood cell transfusions in anemic patients

This is an expanded access IND protocol, and will provide treatment with HBOC-201 to
severely anemic adults for whom blood is not an option.

Available
Intermediate-size Population
Anemia Severe

Biological: HBOC-201

Intravenous administration of a hemoglobin based oxygen carrier (HBOC) in patients with
life-threatening anemia, for whom allogeneic blood transfusion is not an option.
Other Name: Hemopure,hemoglobin glutamer - 250 (bovine)

Eligibility Criteria

Inclusion Criteria:

1. Patients ≥ 18 years of age

2. Critically ill patients with hemoglobin ≤ 6 g/dL (or 7-8 g/dL with significant
active bleeding), and physiologic evidence of critical ischemia, for example:
elevated troponins, altered mental status, acute renal failure, lactic acidosis or
evidence of central nervous system acute deficits

3. Patients or their Legally Authorized Representative who are able and willing to
provide informed consent

4. Blood is not an option due to:

- refusal of transfusion

- lack of compatible red blood cells

Exclusion Criteria:

1. Patients with known hypersensitivity or allergy to beef products

2. Patients with pre-existing uncontrolled hypertension, heart failure, renal failure
(caution should be exercised if renal insufficiency is present), circulatory
hypervolemia or systemic mastocytosis*

3. Patients who are eligible for blood transfusions

4. Patients who are > 80 years old*

5. Pregnant or lactating women

- on a case by case and quality of life determination

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
United States
Locations

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States

Investigator: Amy Monroe
Contact: 4126096161
monroeal@upmc.edu

Contacts

Amy Monroe
412-609-6161
monroeal@upmc.edu

Stephanie Nam
412-722-5477
nams@upmc.edu

HbO2 Therapeutics LLC
NCT Number
Keywords
Hematologic Diseases
Blood Substitutes
MeSH Terms
Anemia
HBOC 201