Prevention of Thromboembolic Events in Total Knee Replacement Patients

• ClinicalTrials.gov Identifier: NCT03393481
• Recruitment Status: Withdrawn
• First Posted: January 8, 2018
• Last Update Posted: October 8, 2020
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

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 (Clinical Trial)
• 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
• Estimated Study Start Date: October 3, 2018
• Estimated Primary Completion Date: January 8, 2020
• Estimated Study Completion Date: April 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

Outcome Measures

Primary Outcome Measures :

1. Number of patients with confirmed composite endpoint [ Time Frame: 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 :

1. Number of patients with composite bleeding [ Time Frame: Day 1 to Day 50 ]
   Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events
2. Number of patients with composite venous thromboembolic events (VTE) [ Time Frame: 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

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03393481
• Other Study ID Numbers: CMAA868A2201; 2017-002925-39 ( EudraCT Number )
• First Posted: January 8, 2018
• Last Update Posted: October 8, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

biologic,; venous thromboembolism,; unilateral knee arthroplasty

Additional relevant MeSH terms:

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Enoxaparin; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action