Status:
ENROLLING_BY_INVITATION
Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia
Lead Sponsor:
Englewood Hospital and Medical Center
Collaborating Sponsors:
HbO2 Therapeutics LLC
Conditions:
Anemia
Eligibility:
All Genders
18-80 years
Phase:
NA
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 u...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01881503
Start Date
October 1 2013
End Date
December 1 2026
Last Update
April 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631