Elective unilateral total knee arthroplasty MedDRA version: 20.0 Level: PT Classification code 10023469 Term: Knee arthroplasty System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Abelacimab
Product Code: MAA868
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Abelacimab
Current Sponsor code: MAA868
Other descriptive name: MAA868
Con
Sponsors
Anthos Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent before any study assessment is performed 2. Male and female patients (= 18 years old and =65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1. Use of other investigational drugs within 5 half-lives of enrollment or until the expected pharmacodynamic effect has returned to baseline, whichever is longer 2. History of hypersensitivity to any of the study drugs (including enoxaparin) or its excipients, to drugs of similar chemical classes or drugs issued from the same biologic origin or any contraindication listed in the label for enoxaparin 3. Any medical condition requiring chronic antithrombotic therapy (e.g. atrial fibrillation, VTE, recent coronary intervention) with the exception of low dose aspirin = 100 mg 4. Known or suspected active bleeding at study entry 5. Macroscopic hematuria or urine dipstick positive for blood 2+ or greater during the screening period 6. Patients at increased risk of bleeding because of a history of increased bleeding tendency (e.g.., history of bleeding diathesis, known active gastrointestinal lesions such as angiodysplasia or an endoscopically verified gastrointestinal ulcer or a history of gastrointestinal bleeding within the past year) or any other condition that in the opinion of the Investigator increases risk of bleeding or patients with a history of intracranial or intraocular bleeding 7. Major surgery including brain, spinal, or ophthalmologic surgery within the past 6 months 8. History of a traumatic spinal or epidural anesthesia or excessive intra- or direct postoperative bleeding 9. Major trauma within the past 6 months 10. History of VTE 11. Malignancy within the past year, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated 12. Myocardial infarction, stroke, or transient ischemic attack in the past 6 months 13. Uncontrolled hypertension (systolic blood pressure =180 mm Hg and/or diastolic blood pressure = 100 mm Hg), based on up to 3 readings at screening 14. Estimated glomerular filtration rate (eGFR) 3x ULN or total bilirubin >2x ULN), diagnosis of liver cirrhosis, history of hepatic encephalopathy, esophageal varices, or portocaval shunt 20. Positive test for human immunodeficiency virus (HIV), positive hepatitis B (hepatitis B surface antigen [HBsAg]) or hepatitis C (anti hepatitis C antibody [Anti-HCV] and confirmed by a positive HCV nucleic acid test) at Screening 21. Clinically significant abnormal ECG, which precludes the patient from surgery, at screening as judged by the Investigator 22. Recent (within the last 12 months) or current history of alcoholism or drug addiction 23. Pregnant or nursing (lactating) women 24. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception, which comply with the surgical intervention planned during the proposed clinical study, during use of study treatments and for 3 days after last treatment of enoxaparin and 110 days after administrat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess if at least one dose of MAA868 is non-inferior to enoxaparin 40 mg through Day 10 after randomization in terms of incidence of adjudicated total VTE in patients undergoing unilateral TKA.;Secondary Objective: • To evaluate the effect of MAA868 relative to enoxaparin in terms of the incidence of major and clinically relevant non-major (CRNM) bleeding events through Day 10 and through Day 30. • To assess if at least one dose of MAA868 is non-inferior to enoxaparin 40 mg through Day 30 and Day 110 (EoS) in terms of the incidence of adjudicated total VTE in patients undergoing unilateral TKA.;Primary end point(s): • Occurrence of confirmed composite endpoint of asymptomatic DVT on the protocol required venography, confirmed symptomatic VTE (including confirmed symptomatic DVT of the leg, fatal or non-fatal PE), or unexplained death for which PE could not be ruled-out during treatment through Day 10.;Timepoint(s) of evaluation of this end point: Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Occurrence of confirmed composite endpoint of major bleeding and CRNM bleeding events through Day 10 and Day 30. 2) Occurrence of confirmed composite endpoint of asymptomatic DVT on the protocol required venography, confirmed symptomatic VTE (including confirmed symptomatic DVT of the leg, fatal or non-fatal PE), or unexplained death for which PE could not be ruled-out during treatment through Day 30 and Day 110.;Timepoint(s) of evaluation of this end point: 1) Day 10 - 30 2) Day 30 - 110 | — |
Countries
Belgium, Bulgaria, Latvia, Lithuania, Poland, Russian Federation, Ukraine
Contacts
Public ContactInformation Desk
Anthos Therapeutics, Inc.
Outcome results
None listed