Expanded Access IND Administration of HBOC-201 in Patients with Severe Acute Anemia

February 10, 2025 updated by: Jonathan H. Waters

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

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

Study Overview

Status

Available

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Available
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonathan H. Waters

Collaborators

HbO2 Therapeutics LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 8, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (Actual)

August 16, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY19070376

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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