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

NCT03633604 | Unknown

• 1 other identifier: STUDY19070376
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anemia Severe

Keywords

Hematologic Diseases; Blood Substitutes

Interventions

HBOC-201 BIOLOGICAL

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

Also known as: Hemopure, hemoglobin glutamer - 250 (bovine)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age
• 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
• Patients or their Legally Authorized Representative who are able and willing to provide informed consent
• Blood is not an option due to:
• refusal of transfusion
• lack of compatible red blood cells

You may not qualify if:

• Patients with known hypersensitivity or allergy to beef products
• Patients with pre-existing uncontrolled hypertension, heart failure, renal failure (caution should be exercised if renal insufficiency is present), circulatory hypervolemia or systemic mastocytosis\*
• Patients who are eligible for blood transfusions
• Patients who are \> 80 years old\*
• Pregnant or lactating women
• on a case by case and quality of life determination

Sponsors & Collaborators

• Jonathan H. Waters: lead
• HbO2 Therapeutics LLC: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

AVAILABLE

MeSH Terms

Conditions

Hematologic Diseases

Interventions

HBOC 201

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Central Study Contacts

Amy Monroe

CONTACT

412-609-6161; monroeal@upmc.edu

Stephanie Nam

CONTACT

412-722-5477; nams@upmc.edu

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 16, 2018
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

US (1)