Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01881503
Recruitment Status : Enrolling by invitation
First Posted : June 19, 2013
Last Update Posted : August 6, 2018
Sponsor:
Collaborator:
HbO2 Therapeutics LLC
Information provided by (Responsible Party):
Englewood Hospital and Medical Center

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 Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : October 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
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 Name: Hemopure




Primary Outcome Measures :
  1. survival [ Time Frame: 1 week ]
    subjects will receive HBOC-201 to treat life-threatening anemia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881503


Locations
Layout table for location information
United States, New Jersey
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
Sponsors and Collaborators
Englewood Hospital and Medical Center
HbO2 Therapeutics LLC
Investigators
Layout table for investigator information
Principal Investigator: Carmine Gianatiempo, MD Englewood Hospital and Medical Center

Additional Information:
Layout table for additonal information
Responsible Party: Englewood Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT01881503     History of Changes
Other Study ID Numbers: E-12-454
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Keywords provided by Englewood Hospital and Medical Center:
life-threatening anemia
blood alternative
HBOC
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia
Hematologic Diseases
HBOC 201
Blood Substitutes