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

Part of paid clinical trials in Englewood, New Jersey.

Sponsor
Englewood Hospital and Medical Center
Study ID
NCT01881503
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 31, 2013
Status verified
Aug 2021
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

survival [ Time Frame: 1 week ]

Locations (1)

FacilityCityStateZIPSite coordinators
Englewood Hospital and Medical CenterEnglewoodNew Jersey07631-

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Englewood Hospital and Medical Center· Englewood, NJ

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