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

NCT00793234 | Completed Phase 2 DMC

• 1 other identifier: TB-402-004
• Study Type: interventional
• Target: 316
• Locations: 7 countries
• Sites: 35

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.

Conditions

Total Knee Replacement Surgery

Keywords

TKR; VTE; DVT

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (4)

1

EXPERIMENTAL

0.3 mg/kg TB-402

Drug: TB-402

2

EXPERIMENTAL

0.6 mg/kg TB-402

Drug: TB-402

3

EXPERIMENTAL

1.2 mg/kg TB-402

Drug: TB-402

4

ACTIVE COMPARATOR

Drug: Enoxaparin

Interventions

TB-402 DRUG

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

1; 2; 3

Enoxaparin DRUG

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

4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged \> 18 and \< 80 years old
• Female patients should be post menopausal
• Patients undergoing primary elective total knee replacement surgery
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• ThromboGenics: lead
• BioInvent International AB: collaborator
• Covance: collaborator

Study Sites (35)

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

Pleven, 5800, Bulgaria

Location

Dept. of Orthopedics, UMHAT "Saint George"

Plovdiv, 4002, Bulgaria

Location

MHAT Rousse

Rousse, 7002, Bulgaria

Location

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

Sofia, 1709, Bulgaria

Location

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

Varna, 9000, Bulgaria

Location

Asaf Harofeh MC

Beer-Yaakov, 70300, Israel

Location

Soroka MC

Beersheba, 84101, Israel

Location

Rambam MC

Haifa, 31096, Israel

Location

Shaare Zedek MC

Jerusalem, 91031, Israel

Location

Meir Medical Center (MC)

Kfar Saba, 44281, Israel

Location

Beilinson Hospital

Petah Tikva, 49100, Israel

Location

Kaplan MC

Rehovot, 76100, Israel

Location

Sourasky MC

Tel Aviv, 64239, Israel

Location

Ltd "Liepajas regionala slimnica"

Liepāja, LV-3400, Latvia

Location

Ltd "Traumatologijas un ortopedijas slimnica"

Riga, LV-1005, Latvia

Location

Vidzemes slimnica

Valmiera, LV 4201, Latvia

Location

Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy Klinika Ortopedii i Traumatologii Narządu Ruchu

Bydgoszcz, 85-094, Poland

Location

Wojewódzki Szpital Specjalistyczny im. L. Rydygiera w Krakowie, Oddział Kliniczny Ortopedii i Traumatologii Narządu Ruchu

Krakow, 31-826, Poland

Location

Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Ortopedii i Traumatologii

Podlaski, 15-276, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Katedra i Klinika Ortopedii Traumatologii i Rehabilitacji

Trzemeszno Lubuskie, 20-090, Poland

Location

Wojewódzki Szpital Bródnowski Samodzielny Publiczny Zakład Opieki Zdrowotnej, Oddział Chirurgii Urazowo-Ortopedycznej i Rehabilitacji

Warsaw, 03-242, Poland

Location

Spitalul Clinic de Urgenta Sf. Ioan Bucuresti

Bucharest, 042122, Romania

Location

Spitalul Clinic de Urgenta Prof. Dr. Octavian Fodor CLUJ NAPOCA

Cluj-Napoca, 400132, Romania

Location

Spitalul Clinic Judetean de Urgenta Craiova

Craiova, 200642, Romania

Location

Municipal Healthcare Institution "City Clinical Hospital No. 3"

Chelyabinsk, 454136, Russia

Location

Moscow State Healthcare Institution "City Clinical Hospital No. 15 n.a. O.M. Filatov"

Moscow, 111539, Russia

Location

Municipal Healthcare Institution "City Clinical Hospital No. 4"

Orenburg, 460000, Russia

Location

Saint Petersburg State Healthcare Institution "Aleksandrovskaya Hospital"

Saint Petersburg, 193312, Russia

Location

Federal State Medical Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency

Saint Petersburg, 194291, Russia

Location

Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2"

Saint Petersburg, 194354, Russia

Location

Federal State Institution "Russian Research Institute of Traumatology and Orthopedics n.a. R.R. Vreden under the Federal Authority for Healthcare and Social Development"

Saint Petersburg, 197046, Russia

Location

State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin"

Samara, 443095, Russia

Location

Cherkasska Regional Hospital. Department of Orthopedics and Traumatology.

Cherkassy, 18009, Ukraine

Location

Ivano-Frankіvsk Regional Clinical Hospital, Department of ortopedics and traumatology.

Ivano-Frankivsk, 76008, Ukraine

Location

Odessa Regional Clinical Hospital, Department of Orthopedics and Traumatology

Odesa, 65025, Ukraine

Location

MeSH Terms

Interventions

TB 402; Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 19, 2008
• Study Start: December 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 7, 2014

Record last verified: 2014-04

Locations

BU (5); LA (3); PL (5); RO (3); IL (8); UA (3); RU (8)