Prevention of Thromboembolic Events in Total Knee Replacement Patients

Thrombotic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03393481
• Other study ID #: CMAA868A2201
• Secondary ID: 2017-002925-39
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 3, 2018
• Est. completion date: April 17, 2020

Study information

• Verified date: October 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 17, 2020
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis
• Thrombotic Disorders

Intervention

Drug:
• MAA868
MAA868 dose 1 and dose 2, single administration, subcutaneous,
• Enoxaparin
Enoxaparin 40 mg, o.d X 10 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with confirmed composite endpoint	Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death	Day 14
Secondary	Number of patients with composite bleeding	Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events	Day 1 to Day 50
Secondary	Number of patients with composite venous thromboembolic events (VTE)	Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death	Day 1 to Day 110