Prevention of Thromboembolic Events in Total Knee Replacement Patients

Study Overview
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Brief Summary
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The purpose of the study is to find out whether MAA868, is able to prevent blood clots following your medical condition (surgery for knee replacement)

Official Title
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A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Active-controlled Phase 2 Study to Compare the Efficacy and Safety of s.c. MAA868 Versus s.c. Enoxaparin in Adult Patients Undergoing Unilateral Total Knee Arthroplasty

Conditions
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Thrombotic Disorders

Intervention / Treatment
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* Drug: MAA868
* Drug: Enoxaparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo elective unilateral total knee arthroplayts (TKA) Willing to comply with study requirements including bilateral venography at Day 12 ± 2 days Body weight between 50 kg and 130 kg inclusive. Normal aPTT, PT, INR at screening Exclusion Criteria: History of arterial or venous thromboembolism; abnormally extended primary or secondary bleeding after trauma or intervention, stroke, transient ischemic attack or traumatic or non-traumatic intracranial bleed; bleeding disorder; MI or unstable angina pectoris within 12 months of the screening; Uncontrolled hypertension (SBP/DBP ≥ 150/95 mmHg at the screening). Medications that increase the risk of bleeding, including antiplatelet (such as aspirin), anticoagulant and fibrinolytic agents; eGFR < 60 mL/min/1.73m2; Poorly controlled diabetes (HbA1C >10%); Liver dysfunction (ALT/AST >3 xULN or TBL >2 x ULN); BMI ≥ 40 kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAA868 dose 1<br>MAA868 dose 1, single administration, subcutaneous | Drug: MAA868<br>* MAA868 dose 1 and dose 2, single administration, subcutaneous,<br>|
| Experimental: MAA868 dose 2<br>MAA868 dose 2, single administration, subcutaneous | Drug: MAA868<br>* MAA868 dose 1 and dose 2, single administration, subcutaneous,<br>|
| Active Comparator: Enoxaparin<br>Enoxaparin 40mg, once daily (o.d.) for 10 days | Drug: Enoxaparin<br>* Enoxaparin 40 mg, o.d X 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with confirmed composite endpoint | Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with composite bleeding | Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events | Day 1 to Day 50 | 
| Number of patients with composite venous thromboembolic events (VTE) | Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death | Day 1 to Day 110 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biologic,, venous thromboembolism,, unilateral knee arthroplasty