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

Anemia Clinical Trial

Official title:

Expanded Access Protocol for the Treatment Use of HBOC-201

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01881503
• Other study ID #: E-12-454
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 2013
• Est. completion date: December 2023

Study information

• Verified date: August 2021
• Source: Englewood Hospital and Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients > = 18 years of age

2. 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

3. Patients or their Legally Authorized Representatives who are able and willing to provide informed consent

Exclusion Criteria:

1. Patients with known hypersensitivity or allergy to beef products

2. 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)

3. Patients > 80 years of age (on a case by case and quality of life determination)

4. Patients who are eligible for blood transfusions

Related Conditions & MeSH terms

• Anemia

Intervention

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

Locations

Country	Name	City	State
United States	Englewood Hospital and Medical Center	Englewood	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Englewood Hospital and Medical Center	HbO2 Therapeutics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival	subjects will receive HBOC-201 to treat life-threatening anemia	1 week

External Links

•   Related Info