Clinical Trial

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

Enrolling by Invitation
View on ClinicalTrials.gov →
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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2013-06-17; most recent amendment 2025-04-11.
Status change: Recruiting → Enrolling by Invitation 2017-07-31
Status change: Not Yet Recruiting → Recruiting 2013-11-01
Trial Details
NCT Number NCT01881503
Lead Sponsor Englewood Hospital and Medical Center
Collaborators: HbO2 Therapeutics LLC
Conditions Anemia
Enrollment 50 participants
Start Date 2013-10
Primary Completion 2026-10 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-13