Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-02 @ 9:33 AM
Study NCT ID:
NCT01881503
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-13
First Post:
2013-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia
Sponsor:
Englewood Hospital and Medical Center
Organization:
Study Overview
Official Title:
Expanded Access Protocol for the Treatment Use of HBOC-201
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
HBOC-201 is not FDA approved for use in the United States, but is approved as an oxygen carrier in South Africa and Russia.
Detailed 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 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: