Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery

ThromboGenics316 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of a single administration of TB-402 for the prevention of VTE in patients undergoing knee replacement surgery.

Currently available anticoagulant therapies for the prevention of VTE include low molecular weight heparins, pentasaccharides and vitamin K antagonists, all of which have inherent limitations(1-3). Improved anticoagulant agents are therefore required(4). A novel antithrombotic agent requires demonstration of both efficacy and safety in relevant populations. Phase II studies are frequently performed in patients undergoing total hip replacement and/or total knee replacement because of the high and well documented incidence of deep vein thrombosis in the absence of adequate thromboprophylaxis(5-7). In this study, we assess the safety and efficacy of TB-402, a novel antithrombotic agent that partially inhibits factor VIII, in the prevention of VTE in patients undergoing total knee replacement surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

316

Conditions

Total Knee Replacement Surgery

Interventions

TB-402DRUG

TB-402 administered as single bolus 18-24 post total knee replacement surgery.

EnoxaparinDRUG

Enoxaparin 40mg/day sc injection for at least 10 days post-surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female patients aged \> 18 and \< 80 years old * Female patients should be post menopausal * Patients undergoing primary elective total knee replacement surgery * Written informed consent obtained from the patient (or a legally acceptable representative) prior to inclusion in the study * Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures Exclusion Criteria: * Body weight \< 50 kg or \> 100 kg * Patients undergoing a hemiarthroplasty, surface repair or revisionary surgery of the knee * Confirmed symptomatic deep vein thrombosis or pulmonary embolism within the past year * Anticipated use of indwelling intrathecal or epidural catheter for more than 4 h after surgery or during the entire study * Uncontrolled hypertension (SBP\>160 mm Hg or DBP \> 100 mm Hg) * History of intracranial or intraocular bleeding. History of gastrointestinal and/or endoscopically verified ulcer disease within the past year

Locations (35)

Outcomes

Primary Outcomes

The occurrence of total bleeding defined as major and/or clinically relevant non-major bleeding events, from randomisation until the end of the study.

Time frame: All visists from randomization to end of study

Composite of the occurrence of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE.

Time frame: Prior to hospital discharge Day 7-11

Secondary Outcomes

Incidence of major bleeding events

Time frame: All visists from randomization to end of study

Incidence of clinically significant non-major bleeding events

Time frame: All visits from randomization to end of study

Incidence of minor bleeding events

Time frame: All visits from randomization to end of study

Incidence of all cause mortality

Time frame: All visits from randomization to end of study

Incidence of adverse events

Time frame: All visists from randomization to end of study

Data from ClinicalTrials.gov

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SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology

Pleven, Bulgaria

Dept. of Orthopedics, UMHAT "Saint George"

Plovdiv, Bulgaria

MHAT Rousse

Rousse, Bulgaria

MHAT "Sveta Anna" AD - Sofia, Clinic of Orthopedics and Traumatology

Sofia, Bulgaria

MHAT "Sv. Anna", Department of Orthopaedics and Traumatology

Varna, Bulgaria

Asaf Harofeh MC

Beer-Yaakov, Israel

Soroka MC

Beersheba, Israel

Rambam MC

Haifa, Israel

Shaare Zedek MC

Jerusalem, Israel

Meir Medical Center (MC)

Kfar Saba, Israel

...and 25 more locations