NCT01881503

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Oct 2013Dec 2026

First Submitted

Initial submission to the registry

June 14, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 13, 2025

Status Verified

August 1, 2021

Enrollment Period

13 years

First QC Date

June 14, 2013

Last Update Submit

April 11, 2025

Conditions

Anemia

Keywords

life-threatening anemiablood alternativeHBOC

Outcome Measures

Primary Outcomes (1)

  • survival

    subjects will receive HBOC-201 to treat life-threatening anemia

    1 week

Study Arms (1)

All subjects

OTHER

all qualifying subjects will receive HBOC-201 (Hemopure) to treat their life-threatening anemia

Biological: HBOC-201

Interventions

HBOC-201BIOLOGICAL

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

Also known as: Hemopure
All subjects

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \> = 18 years of age
  • Patients with hemoglobin \< = 8g/dL with with active bleeding, physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or central nervous system supply dependency
  • Patients or their Legally Authorized Representatives who are able and willing to provide informed consent

You may not qualify if:

  • Patients with known hypersensitivity or allergy to beef products
  • Patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis (on a case by case and quality of life determination)
  • Patients \> 80 years of age (on a case by case and quality of life determination)
  • Patients who are eligible for blood transfusions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Related Links

MeSH Terms

Conditions

Anemia

Interventions

HBOC 201

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Carmine Gianatiempo, MD

    Englewood Hospital and Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2013

First Posted

June 19, 2013

Study Start

October 1, 2013

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 13, 2025

Record last verified: 2021-08

Locations

US(1)