AnemiaNCT02934282
HBOC-201 Expanded Access Protocol for Life-threatening Anemia for Whom Allogeneic Blood Transfusion is Not an Option
A study testing HBOC-201 in people with Anemia, run by Mauricio Lynn at 1 site in United States.
Trial summary
The purpose of this protocol is to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option. Such patients may also be referred to in this document as patients who refuse blood transfusion (PWRBT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anemia
- What is being tested?
- HBOC-201
- 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 < 5 g/dL (or 6-7 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, circulatory hypervolemia or systemic mastocytosis*
- Patients who are eligible for blood transfusions
- Patients who are > 80 years old*
- Pregnant
- Lactating
- on a case by case and quality of life determination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expanded Access Protocol Using HBOC-201
The purpose of this protocol is to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option. Such patients may also be referred to in this document as patients who refuse blood transfusion (PWRBT). Other patients who potentially may require HBOC-201 treatment include those with red blood cell alloantibodies for whom immunologically compatible red blood cell units cannot be found, although these patients are less common than PWRBT.
Read the detailed description
This is an open label intermediate-size patient population expanded access IND protocol.
Due to our experience with management of severely anemic patients for whom blood is not an option, we anticipate encountering future patients with life-threatening anemia for whom blood is not an option. Blood is not an option in the following circumstances:
- refusal of transfusion
- lack of compatible red blood cells due to alloimmunity
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 and the life-threatening anemia persists, then at the investigator's discretion treatment with HBOC-201 will then be considered.
- Conditions
- Anemia
- Being tested
- HBOC-201
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBOC-201Drug
Also called hemoglobin glutamer - 250 (bovine)
Hemoglobin Based Oxygen Carrier (HBOC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- Mauricio Lynn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mauricio Lynn, University of Miami
- Investigators
- Mauricio Lynn, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934282
- Sponsor's protocol ID
- 20160819
- Status last verified
- Dec 2024
- First submitted
- 4 Oct 2016
- Last updated
- 20 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Protocol Using HBOC-201
- ClinicalTrials.gov ID
- NCT02934282
- Acronym / sponsor ID
- 20160819
- Conditions
- Anemia
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Mauricio LynnUniversity, hospital or other
- First posted
- 14 Oct 2016 (estimated)
- 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.
The purpose of this protocol is to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option. Such patients may also be referred to in this document as patients who refuse blood transfusion (PWRBT). Other patients who potentially may require HBOC-201 treatment include those with red blood cell alloantibodies for whom immunologically compatible red blood cell units cannot be found, although these patients are less common than PWRBT.
Detailed description
This is an open label intermediate-size patient population expanded access IND protocol.
Due to our experience with management of severely anemic patients for whom blood is not an option, we anticipate encountering future patients with life-threatening anemia for whom blood is not an option. Blood is not an option in the following circumstances:
- refusal of transfusion
- lack of compatible red blood cells due to alloimmunity
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 and the life-threatening anemia persists, then at the investigator's discretion treatment with HBOC-201 will then be considered.
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 < 5 g/dL (or 6-7 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 (7 listed)
- Patients with known hypersensitivity or allergy to beef products
- Patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis*
- Patients who are eligible for blood transfusions
- Patients who are > 80 years old*
- Pregnant
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: hemoglobin glutamer - 250 (bovine)Hemoglobin Based Oxygen Carrier (HBOC) | Drug | – |
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 Dec 2024.
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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.
Mauricio Lynn principal investigator
University of Miami
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, run by Mauricio Lynn 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 7 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 Dec 2024. 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 Dec 2024.