NCT01881503

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

Expanded Access Protocol for the Treatment Use of HBOC-201

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Englewood Hospital and Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Anemia

Interventions

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

Timeline

• Start date: 2013-10-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2013-06-19
• Last updated: 2025-04-13

Locations

1 site across 1 country: United States