Prevention of Thromboembolic Events in Total Knee Replacement Patients

Novartis

Status and phase: Withdrawn; Phase 2

Conditions: Thrombotic Disorders

Treatments: Drug: Enoxaparin; Drug: MAA868

Study type: Interventional

Funder types: Industry

Identifiers

NCT03393481

CMAA868A2201

2017-002925-39 (EudraCT Number)

Details and patient eligibility

About

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)

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups

MAA868 dose 1

Experimental group

Description:

MAA868 dose 1, single administration, subcutaneous

Treatment:

Drug: MAA868

MAA868 dose 2

Experimental group

Description:

MAA868 dose 2, single administration, subcutaneous

Treatment:

Drug: MAA868

Enoxaparin

Active Comparator group

Description:

Enoxaparin 40mg, once daily (o.d.) for 10 days

Treatment:

Drug: Enoxaparin