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

NCT01881503 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-13

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

HBOC-201

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

Sponsors & Collaborators

  • HbO2 Therapeutics LLC

    collaborator INDUSTRY

  • Englewood Hospital and Medical Center

    lead OTHER

Principal Investigators

  • Carmine Gianatiempo, MD · Englewood Hospital and Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01881503 on ClinicalTrials.gov