Prevention of blood clots following surgery for knee replacement

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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002925-39-ES

Enrollment

600

Registered

2017-12-21

Start date

2018-02-23

Completion date

Unknown

Last updated

2018-08-20

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

Conditions

venous thromboembolism MedDRA version: 20.0 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 100000004866

Interventions

Product Code: MAA868 Pharmaceutical Form: Solution for injection INN or Proposed INN: not available Current Sponsor code: MAA868 Other descriptive name: MAA868 Concentration unit: mg/ml milligram(s)/m

Eligibility

Sex/Gender

All

Inclusion criteria

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. - See full list in protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 450

Exclusion criteria

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 10%); - Liver dysfunction (ALT/AST >3 xULN or TBL >2 x ULN); - BMI = 40 kg/m2. - See full list in protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: Occurrence of confirmed composite endpoint of asymptomatic deep venous thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death.;Secondary Objective: - Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events. - Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death.;Primary end point(s): Number of patients with confirmed composite endpoint.;Timepoint(s) of evaluation of this end point: day 14	—

Measure

Time frame

Main Objective: Occurrence of confirmed composite endpoint of asymptomatic deep venous thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death.;Secondary Objective: - Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events. - Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death.;Primary end point(s): Number of patients with confirmed composite endpoint.;Timepoint(s) of evaluation of this end point: day 14

—

Secondary

Measure	Time frame
Secondary end point(s): Number of patients with composite venous thromboembolic events (VTE).;Timepoint(s) of evaluation of this end point: - day 1 to day 50 and day 1 to day 110	—

Countries

Argentina, Austria, Belgium, Chile, Czech Republic, Estonia, Germany, Hungary, Israel, Italy, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Russian Federation, South Africa, Spain, Turkey

Contacts

Public ContactDepartamento Médico

Novartis Farmacéutica, S.A.

eecc.novartis@novartis.com34900353036

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026