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

Expanded Access Protocol for the Treatment Use of HBOC-201

Status

Enrolling by invitation

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01881503

Enrollment

Registered

2013-06-19

Start date

2013-10-31

Completion date

2026-12-31

Last updated

2025-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

life-threatening anemia, blood alternative, HBOC

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

Interventions

BIOLOGICALHBOC-201

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
survival	1 week	subjects will receive HBOC-201 to treat life-threatening anemia

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026