Prevention of Thromboembolic Events in Total Knee Replacement Patients

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03393481

Collaborator

(none)

Enrollment

Arms

18.5

Anticipated Duration (Months)

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Thrombotic Disorders	Drug: MAA868 Drug: Enoxaparin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Open-label, blinded endpoint assessment

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Oct 3, 2018

Anticipated Primary Completion Date :

Jan 8, 2020

Anticipated Study Completion Date :

Apr 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MAA868 dose 1 MAA868 dose 1, single administration, subcutaneous	Drug: MAA868 MAA868 dose 1 and dose 2, single administration, subcutaneous,
Experimental: MAA868 dose 2 MAA868 dose 2, single administration, subcutaneous	Drug: MAA868 MAA868 dose 1 and dose 2, single administration, subcutaneous,
Active Comparator: Enoxaparin Enoxaparin 40mg, once daily (o.d.) for 10 days	Drug: Enoxaparin Enoxaparin 40 mg, o.d X 10 days

Arm

Intervention/Treatment

Experimental: MAA868 dose 1

MAA868 dose 1, single administration, subcutaneous

Drug: MAA868

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

Experimental: MAA868 dose 2

MAA868 dose 2, single administration, subcutaneous

Drug: MAA868

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

Active Comparator: Enoxaparin

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

Drug: Enoxaparin

Enoxaparin 40 mg, o.d X 10 days

Outcome Measures

Primary Outcome Measures

Number of patients with confirmed composite endpoint [Day 14]
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 [Day 1 to Day 50]
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) [Day 1 to Day 110]
Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT03393481

Other Study ID Numbers:

CMAA868A2201
2017-002925-39

First Posted:

Jan 8, 2018

Last Update Posted:

Oct 8, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Novartis Pharmaceuticals

biologic,

venous thromboembolism,

unilateral knee arthroplasty

Additional relevant MeSH terms:

Thrombosis

Enoxaparin

Study Results

No Results Posted as of Oct 8, 2020