Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaba… (NCT04593784) | Clinical Trial Compass
TerminatedPhase 2
Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults
Stopped: Sponsor decision unrelated to safety
United States41 participantsStarted 2021-10-13
Plain-language summary
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ciraparantag for reversal of anticoagulation induced by different anticoagulant drugs in generally healthy adults as measured primarily by an automated coagulometer device.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Provide written informed consent.
✓. 18 to 75 years of age.
✓. Be in generally good health
✓. BMI 18 to 32 kg/m2, inclusive, at Screening.
✓. If female, be surgically sterile or post-menopausal or if of child-bearing potential, using an acceptable method of contraception (other than a combination estrogen/progestin hormonal contraceptive) for at least 1 month prior to Day 1.
✓. If male, be surgically sterile, or agree to use appropriate contraception.
✓. Have suitable venous access for multiple venipunctures.
Exclusion criteria
✕. Have any of the following findings at Screening:
✕. Hemoglobin or hematocrit value outside the normal range
✕. Platelet count outside the normal range
✕. PT or aPTT outside the normal range
✕. Plasma fibrinogen outside the normal range
✕. Serum triglycerides or total cholesterol outside the normal range
✕. Serum creatinine \>1.5 mg/dL (133 μmol/L) or known renal disease
What they're measuring
1
Subjects Achieving WBCT ≤120% of Baseline
Timeframe: Within 1 hour and sustained through 6 hours