Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia

NCT ID: NCT01881503

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2026-12-31

Brief Summary

The purpose of this expanded access study is to be able to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option.

HBOC-201 is not FDA approved for use in the United States, but is approved as an oxygen carrier in South Africa and Russia.

Detailed Description

i. Initial Dose

For patients with a hemoglobin level less than 6 mg/dl, an initial dose of 32.5 g (one unit) of HBOC 201 is recommended, to be followed by infusion of additional units as necessary to achieve and maintain a total hemoglobin concentration above 6 g/dl, provided that the patient's circulatory volume is properly controlled and will not impose an inappropriate risk.

ii. Subsequent Doses

The need for additional dose administration should be assessed after each infusion as clinically indicated.

Dosing will be stopped if any one of the following occurs:

• resolution of critical ischemia
• death
• recovery of native Hemoglobin levels to > 6 g/dL,
• evidence of reticulocytosis

Conditions

Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All subjects

all qualifying subjects will receive HBOC-201 (Hemopure) to treat their life-threatening anemia

Group Type: OTHER

HBOC-201

Intervention Type: BIOLOGICAL

HBOC-201 is purified, cross-linked, acellular bovine hemoglobin (Hb) in a modified lactated Ringer's solution.

Interventions

HBOC-201

HBOC-201 is purified, cross-linked, acellular bovine hemoglobin (Hb) in a modified lactated Ringer's solution.

Intervention Type: BIOLOGICAL

Other Intervention Names

Hemopure

Eligibility Criteria

Inclusion Criteria

1. Patients > = 18 years of age

2. Patients with hemoglobin < = 8g/dL with with active bleeding, physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or central nervous system supply dependency

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

Exclusion Criteria

1. Patients with known hypersensitivity or allergy to beef products

2. Patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis (on a case by case and quality of life determination)

3. Patients > 80 years of age (on a case by case and quality of life determination)

4. Patients who are eligible for blood transfusions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HbO2 Therapeutics LLC

INDUSTRY

Sponsor Role: collaborator

Englewood Hospital and Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmine Gianatiempo, MD

Role: PRINCIPAL_INVESTIGATOR

Englewood Hospital and Medical Center

Locations

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Countries

United States

Related Links

http://www.englewoodhealth.org

Related Info

Other Identifiers

E-12-454

Identifier Type: -

Identifier Source: org_study_id