Official ClinicalTrials.gov records for Hemopure, HBOC-201 and hemoglobin glutamer-250 (bovine). Registry records are listed separately from journal publications.
How many records were found?
Nine human records were found: six Interventional records and three Expanded Access records. Five of the six interventional records are Phase 2; the sixth is classified as Interventional with phase Not Applicable, despite Expanded Access Study in its title. Four of the five Phase 2 records are randomized. These are not nine randomized controlled trials.
Registry search checked . Each record below retains its own last-update and status-verification dates. Registration does not establish efficacy, approval or current access.
Registry overview. Open an NCT identifier for the full record summary.
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
Official title: Phase II, Multi-Center,Single-Blind,Placebo-Controlled Study,Evaluating Safety & Feasibility of HBOC-201 (Wound Healing Patients With Peripheral Vascular Disease & Undergoing Lower Limb Amputation Due to Critical Lower Limb Ischemia
A Single Site Safety and Tolerability Study of HBOC-201 in Trauma Subjects
Official title: A Single-Center, Study to Evaluate the Safety and Tolerability of Hemoglobin-Based Oxygen Carrier-201 (HBOC 201) in Trauma Subjects. (Phase II - Safety and Tolerability)
Protocol
HEM-0125
Registry status
Unknown
Enrollment
53 (estimated)
Phase
Phase 2
Design
randomized, crossover, single
Participants
Humans, 18 Years to 65 Years
Last update posted
Status last verified
2008-02
The last known status was Recruiting in 2008. Current recruitment is not confirmed.
Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization
Official title: A Multi-Center,Randomized,Double-Blind,Placebo-Controlled,Dose Finding Pilot Study, to Evaluate Safety/Feasibility of HBOC-201 in Elective Percutaneous Coronary Revascularization of Subjects With Acute Coronary Syndromes
Hemoglobin Based Oxygen Therapeutics in Elective Percutaneous Coronary Revascularization
Official title: Phase II, Open-Label Study in the Catheterization Laboratory Setting to Challenge the Concept That HBOC-201 Administration Might Improve Myocardial 'Oxygenation' and Myocardial Function at the Moment of (Brief) Coronary Occlusion
Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia
Official title: Expanded Access Protocol for the Treatment Use of HBOC-201
Protocol
E-12-454
Registry status
Enrolling by invitation
Enrollment
50 (estimated)
Phase
Not applicable / not assigned
Design
na, single group, none
Participants
Humans, 18 Years to 80 Years
Last update posted
Status last verified
2021-08
The title says Expanded Access Study, but the registry classifies this record as Interventional. Status was last verified in August 2021. The listed status does not confirm present access or availability.
Expanded Access IND Administration of HBOC-201 in Patients With Severe Acute Anemia
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
No. The nine human records concern Hemopure / HBOC-201 / hemoglobin glutamer-250. Oxyglobin is the veterinary glutamer-200 formulation. Evidence for either historical product is not proof of a BHOC product's safety, efficacy or approval.
Does Unknown mean Recruiting?
No. NCT00301483 and NCT00301535 have Unknown current status. Recruiting is their last known status from 2008. NCT01881503 lists Enrolling by invitation, with status last verified in August 2021. Confirm any present access directly with the responsible study team.
Are results posted in the registry?
None of these nine records had structured results posted at the check date. This does not establish that journal articles are absent. A publication is linked to an NCT record only after its protocol and participant cohort have been matched.
Are expanded access and marketing approval the same?
No. Expanded access concerns investigational treatment under the relevant regulatory pathway. It is not a marketing approval. Read the FDA expanded-access source note.
How was this list compiled?
The dated API audit checks Oxyglobin, HBOC-301, HBOC-200, hemoglobin glutamer-200, Hemopure, HBOC-201 and hemoglobin glutamer-250, plus a broader Biopure query. The broader query includes unrelated products, which were excluded. This is a product-specific ClinicalTrials.gov search, not an inventory of every historical human HBOC protocol or every registry worldwide.