What the record supports
Access for treatment outside a conventional clinical trial
FDA describes expanded access, sometimes called compassionate use, as a potential pathway for a patient with a serious or immediately life-threatening condition to receive an investigational medical product when there is no comparable or satisfactory alternative and clinical-trial participation is not possible.
The public ClinicalTrials.gov record NCT01881503 is titled Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Patients With Life-Threatening Anemia. It provides a product-specific public record for this U.S. human-use pathway.
Regulatory boundary: expanded access permits investigational treatment under defined conditions. It does not mean the product has FDA marketing approval, and it does not establish general availability, efficacy for every indication or routine clinical use.
Expanded-access IND mechanisms
FDA’s framework permits treatment access on a case-by-case basis for:
- individual patients, including emergency and non-emergency single-patient IND applications;
- intermediate-size patient populations;
- larger populations under a treatment protocol or treatment IND.
- Product identity
- HBOC-201 / Hemopure; FDA’s substance record lists the preferred substance name Hemoglobin glutamer-250 (bovine).
- Public study
- NCT01881503 — expanded access for patients with life-threatening anemia.
- U.S. status
- Investigational treatment access through IND mechanisms; not FDA marketing approval.