Hemopure for Anemia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Englewood Hospital and Medical Center

Disqualifiers: Hypersensitivity to beef, Hypertension, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Hemopure (HBOC-201) for treating anemia?

Research shows that Hemopure (HBOC-201) can effectively deliver oxygen to tissues in cases of severe anemia when blood transfusions are not possible, as demonstrated in a study with 10 patients. Additionally, it has been used successfully in a patient with severe autoimmune anemia, highlighting its potential as an alternative to traditional blood transfusions. ^{1 2 3 4 5}

Is Hemopure (HBOC-201) safe for use in humans?

Hemopure (HBOC-201) has been used in 1,701 patients and was generally well tolerated, though some experienced increased blood pressure, temporary yellowing of the skin, and gastrointestinal symptoms. These effects were manageable and not serious, and there was no evidence of heart damage. It is considered safe when blood transfusions are not an option. ^{1 3 6 7 8}

What makes Hemopure unique for treating anemia?

Hemopure is unique because it is a hemoglobin-based oxygen carrier derived from bovine hemoglobin, which can be used when blood transfusions are not available or possible. It has an extended shelf life, can be stored at room temperature, and helps maintain oxygen delivery in the body, although it may interfere with some lab tests. ^{1 2 5 9 10}

Research Team

Carmine Gianatiempo, MD

Principal Investigator

Englewood Hospital and Medical Center

Eligibility Criteria

This trial is for adults over 18 with severe anemia (hemoglobin <= 8g/dL) who are experiencing life-threatening symptoms like active bleeding or organ issues, and cannot receive blood transfusions. Consent is required. It's not for those allergic to beef, with uncontrolled high blood pressure, heart or kidney failure, fluid overload, mastocytosis, or generally people over 80.

Inclusion Criteria

Patients with hemoglobin <= 8g/dL 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

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

Exclusion Criteria

You need to receive blood transfusions.

You are allergic to beef products.

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive HBOC-201 to treat life-threatening anemia, with dosing adjusted based on clinical need

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HBOC-201

Trial Overview The study provides HBOC-201 (Hemopure), a non-FDA approved treatment in the US but used in South Africa and Russia as an oxygen carrier for patients with critical anemia where blood transfusion isn't an option.

Participant Groups

Group I: All subjects Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Englewood Hospital and Medical Center

Lead Sponsor

Trials

21

Recruited

770+

HbO2 Therapeutics LLC

Industry Sponsor

Trials

3

Recruited

50+

References

1. United States pubmed.ncbi.nlm.nih.gov

A case study of 10 patients administered HBOC-201 in high doses over a prolonged period: outcomes during severe anemia when transfusion is not an option. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Influence of the hemoglobin solution HBOC-201 on tissue oxygenation in the rat R1H-tumor. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Bovine blood and neuromuscular paralysis as a bridge to recovery in a patient with severe autoimmune hemolytic anemia. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Resuscitation with a blood substitute causes vasoconstriction without nitric oxide scavenging in a model of arterial hemorrhage. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Analytical interference of HBOC-201 (Hemopure, a synthetic hemoglobin-based oxygen carrier) on four common clinical chemistry platforms. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Absence of immunopathology associated with repeated IV administration of bovine Hb-based oxygen carrier in dogs. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Users Guide to Pitfalls and Lessons Learned About HBOC-201 During Clinical Trials, Expanded Access, and Clinical Use in 1,701 Patients. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Bovine hemoglobin (glutamer-250, Hemopure)-specific immunoglobulin G antibody cross-reacts with human hemoglobin but does not lyse red blood cells in vitro. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Hemoglobin glutamer-250 (bovine) in South Africa: consensus usage guidelines from clinician experts who have treated patients. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Interference of bovine hemoglobin-based oxygen carrier-201 (Hemopure) on four hematology analyzers. [2023]