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Cow-Hemoglobin drug offers hope for anemia patients who refuse blood

NCT ID NCT02684474

Disease control Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended) This study
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This expanded access program tested HBOC-201 (Hemopure), a liquid oxygen carrier made from cow hemoglobin, in adults with life-threatening anemia who cannot receive blood transfusions. The goal was to improve oxygen delivery to tissues. Participants had very low hemoglobin levels and signs of organ distress. The treatment was given intravenously without needing blood type matching.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HBOC-201 (Hemopure), a lab-made oxygen carrier from cow hemoglobin
What this could lead to
If it works, this could provide a temporary oxygen-boosting option for severely anemic patients who cannot get blood transfusions, potentially saving lives in emergencies.
What could go wrong
This is an expanded access program, not a full trial, so data is limited. HBOC-201 may carry risks like high blood pressure or kidney issues, and it is not a substitute for blood in all cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients ≥ 18 years of age 2. 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 3. Patients or their Legally Authorized Representative who are able and willing to provide informed consent 4. Blood is not an option due to: * refusal of transfusion * lack of compatible red blood cells 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\* 3. Patients who are eligible for blood transfusions 4. Patients who are \> 80 years old\* * on a case by case and quality of life determination

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Conditions

The condition(s) this trial relates to.

anemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia

Contacts and locations

Locations

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.