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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to offer a treatment option using HBOC-201, also known as Hemopure, for individuals with severe anemia when blood transfusions are not possible. Hemopure, an oxygen-carrying solution, has received approval in some countries but not yet in the United States. Participants will receive Hemopure to help manage their condition. This trial suits those with very low hemoglobin levels who experience issues like mental confusion or kidney problems, provided they do not have allergies to beef products or certain other medical conditions. As an unphased trial, this study provides a unique opportunity to access a potentially life-saving treatment not yet available in the U.S.

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 prior data suggests that HBOC-201 is safe for treating life-threatening anemia?

Research has shown that HBOC-201, also known as Hemopure, is generally safe for people. It can be a good option for patients with severe anemia, especially when blood transfusions aren't possible.

In one study, patients with severe anemia who couldn't receive blood transfusions used HBOC-201 safely for an extended period. A review of 21 trials found that HBOC-201 has a good safety record, with few serious side effects.

While the FDA hasn't approved HBOC-201 in the United States, it is approved in South Africa and Russia for carrying oxygen in the body. This indicates that some countries have found it safe and effective to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for anemia, which often include blood transfusions and erythropoiesis-stimulating agents, Hemopure (HBOC-201) offers a different approach by using a hemoglobin-based oxygen carrier. This allows it to transport oxygen throughout the body without the need for cross-matching blood types, reducing the risk of immune reactions. Researchers are excited about Hemopure because it can be used in situations where blood transfusions are not possible or are too risky, offering a potentially lifesaving alternative for patients with life-threatening anemia. Additionally, its stability at room temperature makes it a practical option for use in emergency and remote settings where traditional blood products may not be available.

What evidence suggests that HBOC-201 might be an effective treatment for anemia?

Studies have shown that HBOC-201, also known as Hemopure, can help treat severe anemia, especially when blood transfusions aren't possible. Research indicates that patients who received Hemopure experienced improved oxygen delivery in their bodies. In a study with 10 patients, high doses of Hemopure proved to be safe and practical. The treatment was well tolerated and helped increase oxygen levels, which is vital for patients with severe anemia. Although not approved in the U.S., it is used in other countries and has shown promising results there. In this trial, all qualifying subjects will receive HBOC-201 (Hemopure) to treat their life-threatening anemia. ^{1 3 4 5 6}

Who Is on the Research Team?

Carmine Gianatiempo, MD

Principal Investigator

Englewood Hospital and Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8692657/

New Applications of HBOC-201: A 25-Year Review of the ... The results of these cases supported that long-term and high-dose administration of HBOC-201 is a feasible and safe treatment modality for early ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02934282?tab=table

HBOC-201 Expanded Access Protocol for Life-threatening ... All patients with life-threatening anemia for whom blood is not an option will be treated as per the standard procedure. If those measures are not successful ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32358832/

A case study of 10 patients administered HBOC-201 in ... We present data on 10 Expanded Access (EA) patients treated with high cumulative doses of Hemopure (HBOC-201), to assess the ability of HBOC- ...

4. clinmedjournals.org clinmedjournals.org/articles/ijbrd/international-journal-of-blood-research-and-disorders-ijbrd-7-052.php?jid=ijbrd

Hemopure, HBOC-201, for Life Threatening Anemia in a ... In our experience, Hemopure was well tolerated, and complimented supratherapeutic oxygenation for our elderly patient with life threatening critical anemia.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/trf.15778

A case study of 10 patients administered HBOC‐201 in ... We present data on 10 Expanded Access (EA) patients treated with high cumulative doses of Hemopure (HBOC-201), to assess the ability of HBOC-201 ...

6. eurointervention.pcronline.com eurointervention.pcronline.com/article/hboc-201-the-multi-purpose-oxygen-therapeutic

HBOC-201: The multi-purpose oxygen therapeutic Overall, the data suggest that HBOC-201 has an acceptable toxicity profile. Evaluation of HBOC-201 safety was performed on the results from 21 trials ...