Anemia SevereNCT03633604
Expanded Access IND Administration of HBOC-201 in Patients With Severe Acute Anemia
A study testing HBOC-201 in people with Anemia Severe, run by Michael Boisen at 1 site in United States.
Trial summary
HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, or reduce the need for red blood cell transfusions in anemic patients This is an expanded access IND protocol, and will provide treatment with HBOC-201 to severely anemic adults for whom blood is not an option Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anemia Severe
- What is being tested?
- HBOC-201
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age
- 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
- Patients or their Legally Authorized Representative who are able and willing to provide informed consent
- Blood is not an option due to:
- refusal of transfusion
- lack of compatible red blood cells
Who cannot join
- Patients with known hypersensitivity or allergy to beef products
- Patients with pre-existing uncontrolled hypertension, heart failure, renal failure (caution should be exercised if renal insufficiency is present), circulatory hypervolemia or systemic mastocytosis*
- Patients who are eligible for blood transfusions
- Patients who are > 80 years old*
- Pregnant or lactating women
- on a case by case and quality of life determination
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: An Expanded IND Access Investigation of HBOC-201 Infusion in Patients With Severe Acute Anemia Who Are Unable to Receive Red Blood Cell Transfusion
HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, or reduce the need for red blood cell transfusions in anemic patients
This is an expanded access IND protocol, and will provide treatment with HBOC-201 to severely anemic adults for whom blood is not an option
Read the detailed description
HBOC 201 [hemoglobin glutamer - 250 (bovine)] is an investigational agent, manufactured by Hemoglobin Oxygen Therapeutics LLC (HbO2 Therapeutics), located in Souderton, PA. HBOC-201, has been previously studied17-20 as an alternative to blood transfusions in severely anemic patients needing a way to enhance tissue oxygenation. HBOC-201 is purified, cross-linked and polymerized acellular bovine hemoglobin (Hb) in a modified lactated Ringer's solution, and does not require blood compatibility.
HBOC-201 is an oxygen carrying fluid that increases plasma and total hemoglobin concentration. HBOC-201 has a right-shifted oxygen binding equilibrium curve with a P50 of 40 ± 6 mmHg compared to 27 mmHg for corpuscular hemoglobin. When fully saturated, HBOC-201 binds approximately 1.39 mL of oxygen per gram hemoglobin and, therefore, has the same oxygen carrying capacity as whole blood having the same hemoglobin concentration. To the extent that HBOC-201 administration increases the total hemoglobin concentration in circulation, HBOC-201 is capable of increasing convective oxygen delivery (DO2), defined as the product of blood oxygen content (ml O2/ml blood) and volumetric blood flow (ml blood/min.) At concentrations corresponding to at least 10% of the total hemoglobin concentration, HBOC-201 also facilitates diffusive oxygen delivery, primarily by shortening diffusion distances between RBCs and between RBCs and the endothelium. The higher P50 of HBOC-201 compared to that of cellular hemoglobin further facilitates diffusion of oxygen from RBCs to tissues through increased oxygen off-loading.
HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, or reduce the need for red blood cell transfusions in anemic patients
This is an expanded access IND protocol, and will provide treatment with HBOC-201 to severely anemic adults for whom blood is not an option.
- Conditions
- Anemia Severe
- Being tested
- HBOC-201
- Keywords
- Hematologic Diseases, Blood Substitutes
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBOC-201Biological
Also called Hemopure, hemoglobin glutamer - 250 (bovine)
Intravenous administration of a hemoglobin based oxygen carrier (HBOC) in patients with life-threatening anemia, for whom allogeneic blood transfusion is not an option.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Michael Boisen
- Sponsor type
- University, hospital or other
- Collaborators
- HbO2 Therapeutics LLC
- Responsible party
- Sponsor-investigator, Michael Boisen, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633604
- Sponsor's protocol ID
- STUDY19070376
- Status last verified
- Jul 2026
- First submitted
- 8 Aug 2018
- Last updated
- 20 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded IND Access Investigation of HBOC-201 Infusion in Patients With Severe Acute Anemia Who Are Unable to Receive Red Blood Cell Transfusion
- ClinicalTrials.gov ID
- NCT03633604
- Acronym / sponsor ID
- STUDY19070376
- Conditions
- Anemia Severe
- Keywords
- Hematologic Diseases, Blood Substitutes
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Michael BoisenUniversity, hospital or other
- Collaborators
- HbO2 Therapeutics LLC
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, or reduce the need for red blood cell transfusions in anemic patients
This is an expanded access IND protocol, and will provide treatment with HBOC-201 to severely anemic adults for whom blood is not an option
Detailed description
HBOC 201 [hemoglobin glutamer - 250 (bovine)] is an investigational agent, manufactured by Hemoglobin Oxygen Therapeutics LLC (HbO2 Therapeutics), located in Souderton, PA. HBOC-201, has been previously studied17-20 as an alternative to blood transfusions in severely anemic patients needing a way to enhance tissue oxygenation. HBOC-201 is purified, cross-linked and polymerized acellular bovine hemoglobin (Hb) in a modified lactated Ringer's solution, and does not require blood compatibility.
HBOC-201 is an oxygen carrying fluid that increases plasma and total hemoglobin concentration. HBOC-201 has a right-shifted oxygen binding equilibrium curve with a P50 of 40 ± 6 mmHg compared to 27 mmHg for corpuscular hemoglobin. When fully saturated, HBOC-201 binds approximately 1.39 mL of oxygen per gram hemoglobin and, therefore, has the same oxygen carrying capacity as whole blood having the same hemoglobin concentration. To the extent that HBOC-201 administration increases the total hemoglobin concentration in circulation, HBOC-201 is capable of increasing convective oxygen delivery (DO2), defined as the product of blood oxygen content (ml O2/ml blood) and volumetric blood flow (ml blood/min.) At concentrations corresponding to at least 10% of the total hemoglobin concentration, HBOC-201 also facilitates diffusive oxygen delivery, primarily by shortening diffusion distances between RBCs and between RBCs and the endothelium. The higher P50 of HBOC-201 compared to that of cellular hemoglobin further facilitates diffusion of oxygen from RBCs to tissues through increased oxygen off-loading.
HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, or reduce the need for red blood cell transfusions in anemic patients
This is an expanded access IND protocol, and will provide treatment with HBOC-201 to severely anemic adults for whom blood is not an option.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥ 18 years of age
- 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
- Patients or their Legally Authorized Representative who are able and willing to provide informed consent
- Blood is not an option due to:
Key exclusion criteria (6 listed)
- Patients with known hypersensitivity or allergy to beef products
- Patients with pre-existing uncontrolled hypertension, heart failure, renal failure (caution should be exercised if renal insufficiency is present), circulatory hypervolemia or systemic mastocytosis*
- Patients who are eligible for blood transfusions
- Patients who are > 80 years old*
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBOC-201Also: Hemopure, hemoglobin glutamer - 250 (bovine)Intravenous administration of a hemoglobin based oxygen carrier (HBOC) in patients with life-threatening anemia, for whom allogeneic blood transfusion is not an option. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBOC-201 in people with Anemia Severe, run by Michael Boisen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.