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

ThromboGenics

Status and phase: Completed; Phase 2

Conditions: Total Knee Replacement Surgery

Treatments: Drug: Enoxaparin; Drug: TB-402

Study type: Interventional

Funder types: Industry

Identifiers

NCT00793234

TB-402-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 316 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

316 participants in 4 patient groups

1

Experimental group

Description:

0.3 mg/kg TB-402

Treatment:

Drug: TB-402

2

Experimental group

Description:

0.6 mg/kg TB-402

Treatment:

Drug: TB-402

3

Experimental group

Description:

1.2 mg/kg TB-402

Treatment:

Drug: TB-402

4

Active Comparator group

Treatment:

Drug: Enoxaparin