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Prevention of Thromboembolic Events in Total Knee Replacement Patients

Primary Purpose

Thrombotic Disorders

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

MAA868

Enoxaparin

About this trial

This is an interventional prevention trial for Thrombotic Disorders focused on measuring biologic,, venous thromboembolism,, unilateral knee arthroplasty

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

MAA868 dose 1

MAA868 dose 2

Enoxaparin

Arm Description

MAA868 dose 1, single administration, subcutaneous

MAA868 dose 2, single administration, subcutaneous

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients with composite bleeding

Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events

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

Full Information

NCT ID

NCT03393481

First Posted

January 3, 2018

Last Updated

October 5, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03393481

Brief Title

Prevention of Thromboembolic Events in Total Knee Replacement Patients

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Trial cancelled before First Patient First Visit (no patient enrolled)

Study Start Date

October 3, 2018 (Anticipated)

Primary Completion Date

January 8, 2020 (Anticipated)

Study Completion Date

April 17, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thrombotic Disorders

Keywords

biologic,, venous thromboembolism,, unilateral knee arthroplasty

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Open-label, blinded endpoint assessment

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MAA868 dose 1

Arm Type

Experimental

Arm Description

MAA868 dose 1, single administration, subcutaneous

Arm Title

MAA868 dose 2

Arm Type

Experimental

Arm Description

MAA868 dose 2, single administration, subcutaneous

Arm Title

Enoxaparin

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

MAA868

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Enoxaparin

Intervention Description

Enoxaparin 40 mg, o.d X 10 days

Primary Outcome Measure Information:

Title

Number of patients with confirmed composite endpoint

Description

Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death

Time Frame

Day 14

Secondary Outcome Measure Information:

Title

Number of patients with composite bleeding

Description

Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events

Time Frame

Day 1 to Day 50

Title

Number of patients with composite venous thromboembolic events (VTE)

Description

Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death

Time Frame

Day 1 to Day 110

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

Prevention of Thromboembolic Events in Total Knee Replacement Patients

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