Study of PER977 Administered to Subjects With Steady State Edoxaban Dosing and Re-anticoagulation… (NCT02207257) | Clinical Trial Compass
CompletedPhase 2
Study of PER977 Administered to Subjects With Steady State Edoxaban Dosing and Re-anticoagulation With Edoxaban
United States65 participantsStarted 2014-03
Plain-language summary
This study will evaluate the establishment of anticoagulation ("re-anticoagulation") of subjects with edoxaban following reversal by PER977 and will identify a dose regimen of PER977 that reverses the effects of edoxaban for up to 21 hours.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Adults age 18 to 65 years, inclusive
✓. Laboratory values are not clinically significant
✓. No clinically significant findings on 12-lead electrocardiogram
✓. Body mass index (BMI) 18 to ≤ 32 kg/m2, inclusive
✓. Male subjects agree to use appropriate contraception .
✓. Female subjects may be post-menopausal or, if of child-bearing potential, must have a negative serum pregnancy test prior to enrollment, and must agree to use two forms of acceptable contraception for the duration of the study and for a minimum of one complete menstrual cycle or 28 days following discharge from the study.
✓. Subjects must sign informed consent
Exclusion criteria
✕. History or current evidence of clinically significant disease, liver function tests greater than the upper limit of normal (presence of Gilbert's syndrome is acceptable), QTcF \> normal (440±10 msec for males or 460±10 msec for females).
✕. History of unexplained syncope
✕. History of major bleeding, trauma, surgical procedure of any type, or vaginal delivery within six months prior to screening
✕. History of peptic ulcer, gastrointestinal bleeding, including the mouth, within six months prior to screening
✕
What they're measuring
1
Whole blood clotting time as a measure of edoxaban anticoagulation reversal by PER977
Timeframe: 5 days
Trial details
NCT IDNCT02207257
SponsorPerosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
. History of minor bleeding episodes such as epistaxis, rectal or hemorrhoidal bleeding or gingival bleeding within 1 month prior to screening
✕. Personal or family history of clotting disorder or abnormality, excessive bleeding, thrombovascular disease or any hematologic disorder involving platelets or clotting abnormalities or any condition requiring treatment with transfusions, or history of heparin-induced thrombocytopenia
✕. Females with a history of dysfunctional uterine bleeding, menorrhagia , metrorrhagia or polymenorrhea