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
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|
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
- recovery of native Hemoglobin levels to > 6 g/dL,
- evidence of reticulocytosis
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
all qualifying subjects will receive HBOC-201 (Hemopure) to treat their life-threatening anemia
HBOC-201 is purified, cross-linked, acellular bovine hemoglobin (Hb) in a modified lactated Ringer's solution.
Other Name: Hemopure
- survival [ Time Frame: 1 week ]subjects will receive HBOC-201 to treat life-threatening anemia
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
|United States, New Jersey|
|Englewood Hospital and Medical Center|
|Englewood, New Jersey, United States, 07631|
|Principal Investigator:||Carmine Gianatiempo, MD||Englewood Hospital and Medical Center|