Prevention of Thromboembolic Events in Total Knee Replacement Patients

Phase 2

Withdrawn

• Conditions: Thrombotic Disorders
• Interventions: Drug: MAA868; Drug: Enoxaparin

• Registration Number: NCT03393481
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-08
• Study Start: 2018-10-03
• Primary Completion: 2020-01-08
• Study Completion: 2020-04-17
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAA868 dose 1	MAA868	MAA868 dose 1, single administration, subcutaneous
MAA868 dose 2	MAA868	MAA868 dose 2, single administration, subcutaneous
Enoxaparin	Enoxaparin	Enoxaparin 40mg, once daily (o.d.) for 10 days

Primary Outcome Measures

Name	Time	Method
Number of patients with confirmed composite endpoint	Day 14	Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death

Secondary Outcome Measures

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