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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03393481

Enrollment

Registered

2018-01-08

Start date

2018-10-03

Completion date

2020-04-17

Last updated

2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombotic Disorders

Keywords

biologic,, venous thromboembolism,, unilateral knee arthroplasty

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)

Interventions

DRUGMAA868

MAA868 dose 1 and dose 2, single administration, subcutaneous,

DRUGEnoxaparin

Enoxaparin 40 mg, o.d X 10 days

Study design

Allocation

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Masking description

Open-label, blinded endpoint assessment

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026