Back to resultsExpanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia
Primary Purpose
Anemia
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HBOC-201
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring life-threatening anemia, blood alternative, HBOC
Eligibility Criteria
Inclusion Criteria:
- Patients > = 18 years of age
- Patients with hemoglobin < = 8g/dL with 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:
- Patients with known hypersensitivity or allergy 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)
- Patients > 80 years of age (on a case by case and quality of life determination)
- Patients who are eligible for blood transfusions
Sites / Locations
- Englewood Hospital and Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All subjects
Arm Description
all qualifying subjects will receive HBOC-201 (Hemopure) to treat their life-threatening anemia
Outcomes
Primary Outcome Measures
survival
subjects will receive HBOC-201 to treat life-threatening anemia
Secondary Outcome Measures
Full Information
NCT ID
NCT01881503
First Posted
June 14, 2013
Last Updated
August 16, 2021
Sponsor
Englewood Hospital and Medical Center
Collaborators
HbO2 Therapeutics LLC
1. Study Identification
Unique Protocol Identification Number
NCT01881503
Brief Title
Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia
Official Title
Expanded Access Protocol for the Treatment Use of HBOC-201
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Englewood Hospital and Medical Center
Collaborators
HbO2 Therapeutics LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
i. Initial Dose
For patients with a hemoglobin level less than 6 mg/dl, an initial dose of 32.5 g (one unit) of HBOC 201 is recommended, to be followed by infusion of additional units as necessary to achieve and maintain a total hemoglobin concentration above 6 g/dl, provided that the patient's circulatory volume is properly controlled and will not impose an inappropriate risk.
ii. Subsequent Doses
The need for additional dose administration should be assessed after each infusion as clinically indicated.
Dosing will be stopped if any one of the following occurs:
resolution of critical ischemia
death
recovery of native Hemoglobin levels to > 6 g/dL,
evidence of reticulocytosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
life-threatening anemia, blood alternative, HBOC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All subjects
Arm Type
Other
Arm Description
all qualifying subjects will receive HBOC-201 (Hemopure) to treat their life-threatening anemia
Intervention Type
Biological
Intervention Name(s)
HBOC-201
Other Intervention Name(s)
Hemopure
Intervention Description
HBOC-201 is purified, cross-linked, acellular bovine hemoglobin (Hb) in a modified lactated Ringer's solution.
Primary Outcome Measure Information:
Title
survival
Description
subjects will receive HBOC-201 to treat life-threatening anemia
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients > = 18 years of age
Patients with hemoglobin < = 8g/dL with 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:
Patients with known hypersensitivity or allergy 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)
Patients > 80 years of age (on a case by case and quality of life determination)
Patients who are eligible for blood transfusions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmine Gianatiempo, MD
Organizational Affiliation
Englewood Hospital and Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.englewoodhealth.org
Description
Related Info
Learn more about this trial
Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia
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