Prevention of Thromboembolic Events in Total Knee Replacement Patients

NCT ID: NCT03393481

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-03
• Study Completion Date: 2020-04-17

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)

Conditions

Thrombotic Disorders

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

MAA868 dose 1

MAA868 dose 1, single administration, subcutaneous

Group Type: EXPERIMENTAL

MAA868

Intervention Type: DRUG

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

MAA868 dose 2

MAA868 dose 2, single administration, subcutaneous

Group Type: EXPERIMENTAL

MAA868

Intervention Type: DRUG

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

Enoxaparin

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

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

Enoxaparin 40 mg, o.d X 10 days

Interventions

MAA868

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

Intervention Type: DRUG

Enoxaparin

Enoxaparin 40 mg, o.d X 10 days

Intervention Type: DRUG

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2017-002925-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CMAA868A2201

Identifier Type: -

Identifier Source: org_study_id