Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia

Sponsor

Englewood Hospital and Medical Center (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT01881503

Collaborator

HbO2 Therapeutics LLC (Industry)

Enrollment

Location

Arm

122

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia	Biological: HBOC-201	N/A

Detailed Description

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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Expanded Access Protocol for the Treatment Use of HBOC-201

Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: All subjects all qualifying subjects will receive HBOC-201 (Hemopure) to treat their life-threatening anemia	Biological: HBOC-201 HBOC-201 is purified, cross-linked, acellular bovine hemoglobin (Hb) in a modified lactated Ringer's solution. Other Names: Hemopure

Arm

Intervention/Treatment

Other: All subjects

all qualifying subjects will receive HBOC-201 (Hemopure) to treat their life-threatening anemia

Biological: HBOC-201

HBOC-201 is purified, cross-linked, acellular bovine hemoglobin (Hb) in a modified lactated Ringer's solution.

Other Names:

Hemopure

Outcome Measures

Primary Outcome Measures

survival [1 week]
subjects will receive HBOC-201 to treat life-threatening anemia

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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