Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-01 @ 6:52 AM
Study NCT ID:
NCT03633604
Status:
AVAILABLE
Last Update Posted:
2025-02-11
First Post:
2018-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access IND Administration of HBOC-201 in Patients With Severe Acute Anemia
Sponsor:
Jonathan H. Waters
Organization:
Study Overview
Official Title:
An Expanded IND Access Investigation of HBOC-201 Infusion in Patients With Severe Acute Anemia Who Are Unable to Receive Red Blood Cell Transfusion
Status:
AVAILABLE
Status Verified Date:
2025-02
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:
HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, or reduce the need for red blood cell transfusions in anemic patients
This is an expanded access IND protocol, and will provide treatment with HBOC-201 to severely anemic adults for whom blood is not an option
This is an expanded access IND protocol, and will provide treatment with HBOC-201 to severely anemic adults for whom blood is not an option
Detailed Description:
HBOC 201 \[hemoglobin glutamer - 250 (bovine)\] is an investigational agent, manufactured by Hemoglobin Oxygen Therapeutics LLC (HbO2 Therapeutics), located in Souderton, PA. HBOC-201, has been previously studied17-20 as an alternative to blood transfusions in severely anemic patients needing a way to enhance tissue oxygenation. HBOC-201 is purified, cross-linked and polymerized acellular bovine hemoglobin (Hb) in a modified lactated Ringer's solution, and does not require blood compatibility.
HBOC-201 is an oxygen carrying fluid that increases plasma and total hemoglobin concentration. HBOC-201 has a right-shifted oxygen binding equilibrium curve with a P50 of 40 ± 6 mmHg compared to 27 mmHg for corpuscular hemoglobin. When fully saturated, HBOC-201 binds approximately 1.39 mL of oxygen per gram hemoglobin and, therefore, has the same oxygen carrying capacity as whole blood having the same hemoglobin concentration. To the extent that HBOC-201 administration increases the total hemoglobin concentration in circulation, HBOC-201 is capable of increasing convective oxygen delivery (DO2), defined as the product of blood oxygen content (ml O2/ml blood) and volumetric blood flow (ml blood/min.) At concentrations corresponding to at least 10% of the total hemoglobin concentration, HBOC-201 also facilitates diffusive oxygen delivery, primarily by shortening diffusion distances between RBCs and between RBCs and the endothelium. The higher P50 of HBOC-201 compared to that of cellular hemoglobin further facilitates diffusion of oxygen from RBCs to tissues through increased oxygen off-loading.
HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, or reduce the need for red blood cell transfusions in anemic patients
This is an expanded access IND protocol, and will provide treatment with HBOC-201 to severely anemic adults for whom blood is not an option.
HBOC-201 is an oxygen carrying fluid that increases plasma and total hemoglobin concentration. HBOC-201 has a right-shifted oxygen binding equilibrium curve with a P50 of 40 ± 6 mmHg compared to 27 mmHg for corpuscular hemoglobin. When fully saturated, HBOC-201 binds approximately 1.39 mL of oxygen per gram hemoglobin and, therefore, has the same oxygen carrying capacity as whole blood having the same hemoglobin concentration. To the extent that HBOC-201 administration increases the total hemoglobin concentration in circulation, HBOC-201 is capable of increasing convective oxygen delivery (DO2), defined as the product of blood oxygen content (ml O2/ml blood) and volumetric blood flow (ml blood/min.) At concentrations corresponding to at least 10% of the total hemoglobin concentration, HBOC-201 also facilitates diffusive oxygen delivery, primarily by shortening diffusion distances between RBCs and between RBCs and the endothelium. The higher P50 of HBOC-201 compared to that of cellular hemoglobin further facilitates diffusion of oxygen from RBCs to tissues through increased oxygen off-loading.
HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, or reduce the need for red blood cell transfusions in anemic patients
This is an expanded access IND protocol, and will provide treatment with HBOC-201 to severely anemic adults for whom blood is not an option.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: