Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anemia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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 circ...
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
Tracking Information
- NCT #
- NCT01881503
- Collaborators
- HbO2 Therapeutics LLC
- Investigators
- Principal Investigator: Carmine Gianatiempo, MD Englewood Hospital and Medical Center
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