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

Phase 2

Completed

• Conditions: Total Knee Replacement Surgery
• Interventions: Drug: TB-402; Drug: Enoxaparin

• Registration Number: NCT00793234
• Lead Sponsor: ThromboGenics

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2008-11-18
• Study First Submitted QC: 2008-11-18
• Study First Posted: 2008-11-19
• Study Start: 2008-12
• Primary Completion: 2010-01
• Study Completion: 2010-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	TB-402	0.3 mg/kg TB-402
3	TB-402	1.2 mg/kg TB-402
2	TB-402	0.6 mg/kg TB-402
4	Enoxaparin	-

Primary Outcome Measures

Name	Time	Method
The occurrence of total bleeding defined as major and/or clinically relevant non-major bleeding events, from randomisation until the end of the study.	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.	Prior to hospital discharge Day 7-11

Secondary Outcome Measures

Name	Time	Method
Incidence of major bleeding events	All visists from randomization to end of study
Incidence of clinically significant non-major bleeding events	All visits from randomization to end of study
Incidence of minor bleeding events	All visits from randomization to end of study
Incidence of all cause mortality	All visits from randomization to end of study
Incidence of adverse events	All visists from randomization to end of study

Trial Locations

Locations (35)

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

Soroka MC; 🇮🇱 Beer - Sheva, Israel

Asaf Harofeh MC; 🇮🇱 Beer-Yaakov, Israel

Rambam MC; 🇮🇱 Haifa, Israel

Shaare Zedek MC; 🇮🇱 Jerusalem, Israel

Meir Medical Center (MC); 🇮🇱 Kfar Saba, Israel

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