Study Stopped
Trial cancelled before First Patient First Visit (no patient enrolled)
Prevention of Thromboembolic Events in Total Knee Replacement Patients
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
2 other identifiers
interventional
N/A
0 countries
N/A
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2018
CompletedFirst Posted
Study publicly available on registry
January 8, 2018
CompletedStudy Start
First participant enrolled
October 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2020
CompletedOctober 8, 2020
October 1, 2020
1.3 years
January 3, 2018
October 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of patients with composite bleeding
Day 1 to Day 50
Number of patients with composite venous thromboembolic events (VTE)
Day 1 to Day 110
Study Arms (3)
MAA868 dose 1
EXPERIMENTALMAA868 dose 1, single administration, subcutaneous
MAA868 dose 2
EXPERIMENTALMAA868 dose 2, single administration, subcutaneous
Enoxaparin
ACTIVE COMPARATOREnoxaparin 40mg, once daily (o.d.) for 10 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Open-label, blinded endpoint assessment
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2018
First Posted
January 8, 2018
Study Start
October 3, 2018
Primary Completion
January 8, 2020
Study Completion
April 17, 2020
Last Updated
October 8, 2020
Record last verified: 2020-10