Acute Anemia Clinical Trial
Official title:
An Open-label Phase 1 Safety Study of SANGUINATE™ Infusion in Patients With Acute Severe Anemia Who Are Unable to Receive Red Blood Cell Transfusion
| Verified date | May 2017 |
| Source | Prolong Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
In this open-label study, eligible and consenting adult patients admitted to the hospital for critical care that have acute severe anemia, defined as a blood hemoglobin level ≤ 5 g/dL, but who are unwilling or unable to receive red blood cell (RBC) transfusion, will receive one or more infusions of SANGUINATE as are deemed necessary by the Investigator for survival of the acute anemic episode.
| Status | Completed |
| Enrollment | 103 |
| Est. completion date | May 17, 2017 |
| Est. primary completion date | May 17, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. The patient would otherwise receive RBC transfusion for treatment of severe anemia but cannot (hemolytic/allosensitized or no compatible blood) or will not (religious/personal objection) receive RBCs 2. Hemoglobin = 5 g/dL, or hemoglobin = 7 g/dL following a decline of = 5 g/dL over less than 7 days 3. Age = 18 years 4. Receiving or willing to receive supplemental iron therapy (unless contraindicated) 5. Receiving or willing to receive erythropoiesis-stimulating agent (EPO) therapy 6. Patient or legally authorized representative provided consent to participate 7. Investigator determination that the patient is an appropriate candidate for study enrollment Exclusion Criteria: 1. Hemoglobin = 2 g/dL 2. Presence of severe trauma (e.g., Injury Severity Score (ISS)/New Injury Severity Score (NISS) Score = 25) 3. Unable to provide sufficient blood sample volume for screening assessments; or 4. Pregnant; or 5. Investigator determination that the patient is not an appropriate candidate for study enrollment |
| Country | Name | City | State |
|---|---|---|---|
| United States | Abington University | Abington | Pennsylvania |
| United States | Augusta University | Augusta | Georgia |
| United States | Kaiser Permanente | Baldwin Park | California |
| United States | Johns Hopkins University | Baltimore | Maryland |
| United States | Brookwood Princeton Baptist | Birmingham | Alabama |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Presbyterian Hospital Novant Health | Charlotte | North Carolina |
| United States | Detroit Medical Center Harper Univesity Hospital | Detroit | Michigan |
| United States | City of Hope | Duarte | California |
| United States | University of Texas Medical Center (El Paso) | El Paso | Texas |
| United States | Englewood Medical Center | Englewood | New Jersey |
| United States | Bon Secour St Francis Cancer Center | Greenville | South Carolina |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | St. Lukes | Houston | Texas |
| United States | Northwell - North Shore University Hospital | Lake Success | New York |
| United States | Antelope Valley Hospital | Lancaster | California |
| United States | St. Barnabas | Livingston | New Jersey |
| United States | Loma Linda Medical Center | Loma Linda | California |
| United States | Wellstar Atlanta Medical Centre | Marietta | Georgia |
| United States | Blood Center of Wisconsin | Milwaukee | Wisconsin |
| United States | Providence Holy Cross Hospital | Mission Hills | California |
| United States | Mt. Sinai /Recanati/Miller Transplantation Institute, Icahn | New York | New York |
| United States | Hahnemann University Hospital (Rittenhouse) | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | Yavapai Regional Medical Center | Prescott | Arizona |
| United States | Virginia Commonwealth University | Richmond | Virginia |
| United States | Swedish Medical Center | Seattle | Washington |
| United States | Tampa General Hospital | Tampa | Florida |
| United States | Medstar Georgetown University Hosiptal | Washington, D.C. | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Prolong Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number and severity of adverse events within 24-hours of each SANGUINATE infusion | Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, death and other reported adverse events | 24 Hours | |
| Secondary | Percentage of patients who survive the acute episode of severe anemia | 14 Days | ||
| Secondary | Percentage of patients who recover from hypoxia-induced abnormal end-organ function | 14 Days | ||
| Secondary | Percentage of patients who improved with their hemodynamic status | 14 Days | ||
| Secondary | Percentage of patients who discontinue inotrope therapy | 14 Days | ||
| Secondary | Percentage of patients who discontinue respiratory support/therapy | 14 Days | ||
| Secondary | Number of serious adverse events following the start of SANGUINATE infusions through the final visit (up to 28 days) | Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, death and other reported serious adverse events | 28 Days |