A Phase 1 interventional study of SANGUINATE™ in Acute Anemia, sponsored by Prolong Pharmaceuticals. Completed at 32 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-27.
Sponsored by Prolong Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
Data collection for each patient during the in-patient portion of the study will be required for up to a maximum of 14 days while under critical care, with additional collection of safety-related findings at 7 days and 14 days after the last infusion of SANGUINATE. Each patient will thus have up to 28 days participation in the trial.
A minimum of 100 subjects are to be enrolled and to receive at least one infusion of SANGUINATE, with 14-day follow-up after the last infusion.
Because of the life-threatening effects of severe anemia, it is expected that all patients in this trial will receive care within a critical care facility (may be called intensive care or some similar name), wherein all patients will have real-time monitoring of vital signs and ECG (e.g., by telemetry) before, during, and after all study drug infusions.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 103 is close to the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Prolong Pharmaceuticals is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
As Needed Dosing of SANGUINATE
Drug: SANGUINATE™
As needed (PRN) infusions of 500 mL of SANGUINATE
Also known as: pegylated carboxyhemoglobin bovine
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
Time frame: 24 Hours
Percentage of patients who survive the acute episode of severe anemia
Time frame: 14 Days
Percentage of patients who recover from hypoxia-induced abnormal end-organ function
Time frame: 14 Days
Percentage of patients who improved with their hemodynamic status
Time frame: 14 Days
Percentage of patients who discontinue inotrope therapy
Time frame: 14 Days
Percentage of patients who discontinue respiratory support/therapy
Time frame: 14 Days
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
Time frame: 28 Days
Plan to share: No
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Prolong Pharmaceuticals