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A Phase 1 Safety Study of SANGUINATE™ In Patients With Acute Severe Anemia.

NCT02754999 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2017-06-27

No results posted yet for this study

Summary

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.

Conditions

  • Acute Anemia

Interventions

DRUG

SANGUINATE™

As needed (PRN) infusions of 500 mL of SANGUINATE

Sponsors & Collaborators

  • Prolong Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Abe Abuchowski, PhD · Prolong Pharamceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-05-17
Completion
2017-05-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02754999 on ClinicalTrials.gov