Loading clinical trials...

Prevention of Thromboembolic Events in Total Knee Replacement Patients | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Prevention of Thromboembolic Events in Total Knee Replacement Patients

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

NCT03393481•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

October 3, 2018

Primary Completion Date

January 8, 2020

Completion Date

April 17, 2020

Last Updated

October 8, 2020

Conditions

Thrombotic Disorders

Interventions

MAA868

DRUG

Enoxaparin

DRUG

Determination of Fibrin Activity in Plasma on STA-R® Prototype

NCT02856789

Blood Coagulation DisordersThrombotic Disorders+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions