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

Status Enrolling by invitation

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Anemia

• NCT number: NCT01881503
• Study type: Interventional
• Source: Englewood Hospital and Medical Center
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 2013
• Completion date: December 2023