Study to Evaluate Efficacy and Safety of BGE-117 in Moderately to Severely Anemic Older Individua… (NCT05152641) | Clinical Trial Compass
WithdrawnPhase 2
Study to Evaluate Efficacy and Safety of BGE-117 in Moderately to Severely Anemic Older Individuals After Major Hip Surgery
Stopped: The program priority for execution of this clinical trial changed prior to enrollment of the first patient. The study was not withdrawn due to any safety concerns.
Australia0Started 2022-04
Plain-language summary
The purpose of this study is to explore the safety and tolerability of BGE-117 and gain information on the effectiveness of different doses when given to patients 65 years or older with moderate to severe anemia following major hip surgery. BGE-117 is given once daily in a capsule by mouth for up to 12 weeks. Patients are also given oral iron supplements. Anemia following surgery has been associated with decreases in patient functioning. This study will measure improvement of anemia, as well as various patient functioning.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. Alert and able to voluntarily provide written, signed, and dated informed consent
✓. ≥ 65 years of age at the time of completing informed consent
✓. Major hip surgery, that has occurred within the previous 7 days or is scheduled to occur within the next 7 days, defined as:
✓. Postoperative anemia defined as a hemoglobin level ≤ 10.0 g/dL and ≥ 7.0 g/dL from postoperative Day 1 to postoperative Day 7
✓. For hip fracture subjects only: score between 1 and 5 on the Clinical Frailty Scale (CFS) at baseline before fracture
✓. Estimated glomerular filtration rate (eGFR) of ≥ 60 mL/min/m2 as measured by the Modification of Diet in Renal Disease (MDRD) method
✓. Current or planned perioperative use of mechanical or chemical antithrombotic prophylaxis in accordance with local standard of care
Exclusion criteria
✕. Any current unstable medical condition that the investigator considers would put the subject at unacceptable risk, affect study compliance, or prevent the understanding of the study's objectives or investigational procedures or possible consequences; for example, increased risk of falls that is judged to be clinically significant, clinically significant autonomic dysfunction, active infections requiring antimicrobial treatment
✕. History of thromboembolic disease in the previous 6 months
✕. Other medically significant injuries (e.g., head injuries, internal bleeding, or other as judged by the study investigator) that occur concurrently with hip fractures that complicate endpoint assessments, subject safety, and/or study conduct
✕. History of seizures within the previous 2 years
✕. History of coagulation disorder (e.g., Factor V Leiden, idiopathic thrombocytopenic purpura) or use of concomitant medications that increase the risk of thromboembolic events (TEEs) as judged by the study investigator
✕. Class III or IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system
✕. QTcF \> 500 msec or QTcF \> 530 msec in subjects with bundle branch block. A triplicate electrocardiogram (ECG) should be performed if the initial ECG indicates prolonged QTc interval using the automated or manually calculated QTcF value.
✕. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥ 3 × the upper limit of normal (ULN) (Historical standard-of-care laboratory results may be used to confirm eligibility if collected within 14 days before informed consent)