Prevention of Thromboembolic Events in Total Knee Replacement Patients

• Status: Withdrawn
• Trial end date: 2020-04-17
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Enoxaparin

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