This study was to compare the study drug KN060 to enoxaparin, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
241
40 mg enoxaparin administered as subcutaneous injection once daily
Single dose of KN060 administered as intravenous infusion
Single dose of KN060 administered as intravenous infusion
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded
DVT - Deep vein thrombosis / PE - Pulmonary embolism. All suspected events were reviewed and classified by the investigator
Time frame: Up to 14 days
Incidence of composite endpoint of major and clinically relevant non-major bleeding
All suspected events were reviewed and classified by the investigator
Time frame: Up to 14 days
Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded
All suspected events were reviewed and classified by the investigator
Time frame: Up to 35\100 days
Incidence of symptomatic DVT, non-fatal PE
All suspected events were reviewed and classified by the investigator
Time frame: Up to 14 \35\100 days
Incidence of fatal PE
All suspected events were reviewed and classified by the investigator
Time frame: Up to 14 \35\100 days
Incidence of unexplained death for which PE cannot be excluded
All suspected events were reviewed and classified by the investigator
Time frame: Up to 14 \35\100 days
Incidence of composite endpoint of major and clinically relevant non-major bleeding
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Single dose of KN060 administered as intravenous infusion
All suspected events were reviewed and classified by the investigator
Time frame: Up to 35\100 days
Incidence of bleeding
All suspected events were reviewed and classified by the investigator
Time frame: Up to 14 \35\100 days
Incidence of major bleeding
All suspected events were reviewed and classified by the investigator
Time frame: Up to 14 \35\100 days
Incidence of clinically relevant non-major bleeding
All suspected events were reviewed and classified by the investigator
Time frame: Up to 14 \35\100 days
Incidence of treatment emergent adverse event/adverse drug reaction
All suspected events were reviewed and classified by the investigator
Time frame: Up to 14 \35\100 days
Plasma Concentration of KN060
Time frame: Up to 100 days
Pharmacodynamics index: Changes of plasma concentration of Free FⅪ from baseline;
Free FⅪ: Free Factor XI; Factor XI is a clotting factor.
Time frame: Up to 100 days
Pharmacodynamics index: Changes of FⅪ activity from baseline;
FⅪ: Factor XI; Factor XI is a clotting factor.
Time frame: Up to 100 days
Pharmacodynamics index: Changes of APTT from baseline;
APTT: activated partial thromboplastin time;
Time frame: Up to 100 days