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

Primary Purpose

Total Knee Replacement Surgery

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

TB-402

Enoxaparin

About this trial

This is an interventional prevention trial for Total Knee Replacement Surgery focused on measuring TKR, VTE, DVT

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology
Dept. of Orthopedics, UMHAT "Saint George"
MHAT Rousse
MHAT "Sveta Anna" AD - Sofia, Clinic of Orthopedics and Traumatology
MHAT "Sv. Anna", Department of Orthopaedics and Traumatology
Soroka MC
Asaf Harofeh MC
Rambam MC
Shaare Zedek MC
Meir Medical Center (MC)
Beilinson Hospital
Kaplan MC
Sourasky MC
Ltd "Liepajas regionala slimnica"
Ltd "Traumatologijas un ortopedijas slimnica"
Vidzemes slimnica
Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy Klinika Ortopedii i Traumatologii Narządu Ruchu
Wojewódzki Szpital Specjalistyczny im. L. Rydygiera w Krakowie, Oddział Kliniczny Ortopedii i Traumatologii Narządu Ruchu
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Katedra i Klinika Ortopedii Traumatologii i Rehabilitacji
Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Ortopedii i Traumatologii
Wojewódzki Szpital Bródnowski Samodzielny Publiczny Zakład Opieki Zdrowotnej, Oddział Chirurgii Urazowo-Ortopedycznej i Rehabilitacji
Spitalul Clinic de Urgenta Sf. Ioan Bucuresti
Spitalul Clinic de Urgenta Prof. Dr. Octavian Fodor CLUJ NAPOCA
Spitalul Clinic Judetean de Urgenta Craiova
Municipal Healthcare Institution "City Clinical Hospital No. 3"
Moscow State Healthcare Institution "City Clinical Hospital No. 15 n.a. O.M. Filatov"
Municipal Healthcare Institution "City Clinical Hospital No. 4"
Federal State Medical Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency
Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2"
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 State Healthcare Institution "Aleksandrovskaya Hospital"
State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
Cherkasska Regional Hospital. Department of Orthopedics and Traumatology.
Ivano-Frankіvsk Regional Clinical Hospital, Department of ortopedics and traumatology.
Odessa Regional Clinical Hospital, Department of Orthopedics and Traumatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

0.3 mg/kg TB-402

0.6 mg/kg TB-402

1.2 mg/kg TB-402

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of major bleeding events

Incidence of clinically significant non-major bleeding events

Incidence of minor bleeding events

Incidence of all cause mortality

Incidence of adverse events

Full Information

NCT ID

NCT00793234

First Posted

November 18, 2008

Last Updated

April 4, 2014

Sponsor

ThromboGenics

Collaborators

BioInvent International AB, Covance

1. Study Identification

Unique Protocol Identification Number

NCT00793234

Brief Title

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

Official Title

Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery: A Dose-Escalating, Multicenter, Randomised, Active- Controlled Open Label Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ThromboGenics

Collaborators

BioInvent International AB, Covance

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Total Knee Replacement Surgery

Keywords

TKR, VTE, DVT

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

316 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

0.3 mg/kg TB-402

Arm Title

Arm Type

Experimental

Arm Description

0.6 mg/kg TB-402

Arm Title

Arm Type

Experimental

Arm Description

1.2 mg/kg TB-402

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

TB-402

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Enoxaparin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

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 Outcome Measure Information:

Title

Incidence of major bleeding events

Time Frame

All visists from randomization to end of study

Title

Incidence of clinically significant non-major bleeding events

Time Frame

All visits from randomization to end of study

Title

Incidence of minor bleeding events

Time Frame

All visits from randomization to end of study

Title

Incidence of all cause mortality

Time Frame

All visits from randomization to end of study

Title

Incidence of adverse events

Time Frame

All visists from randomization to end of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

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

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Dept. of Orthopedics, UMHAT "Saint George"

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

MHAT Rousse

City

Rousse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

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

City

Sofia

ZIP/Postal Code

1709

Country

Bulgaria

Facility Name

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

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Soroka MC

City

Beer - Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

Asaf Harofeh MC

City

Beer-Yaakov

ZIP/Postal Code

70300

Country

Israel

Facility Name

Rambam MC

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Shaare Zedek MC

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Meir Medical Center (MC)

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Beilinson Hospital

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Kaplan MC

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Sourasky MC

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Ltd "Liepajas regionala slimnica"

City

Liepāja

ZIP/Postal Code

LV-3400

Country

Latvia

Facility Name

Ltd "Traumatologijas un ortopedijas slimnica"

City

Riga

ZIP/Postal Code

LV-1005

Country

Latvia

Facility Name

Vidzemes slimnica

City

Valmiera

ZIP/Postal Code

LV 4201

Country

Latvia

Facility Name

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

City

Bydgoszcz

ZIP/Postal Code

85-094

Country

Poland

Facility Name

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

City

Kraków

ZIP/Postal Code

31-826

Country

Poland

Facility Name

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

City

Lubuskie

ZIP/Postal Code

20-090

Country

Poland

Facility Name

Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Ortopedii i Traumatologii

City

Podlaski

ZIP/Postal Code

15-276

Country

Poland

Facility Name

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

City

Warszawa

ZIP/Postal Code

03-242

Country

Poland

Facility Name

Spitalul Clinic de Urgenta Sf. Ioan Bucuresti

City

Bucuresti

ZIP/Postal Code

042122

Country

Romania

Facility Name

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

City

Cluj - Napoca

ZIP/Postal Code

400132

Country

Romania

Facility Name

Spitalul Clinic Judetean de Urgenta Craiova

City

Craiova

ZIP/Postal Code

200642

Country

Romania

Facility Name

Municipal Healthcare Institution "City Clinical Hospital No. 3"

City

Cheliabinsk

ZIP/Postal Code

454136

Country

Russian Federation

Facility Name

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

City

Moscow

ZIP/Postal Code

111539

Country

Russian Federation

Facility Name

Municipal Healthcare Institution "City Clinical Hospital No. 4"

City

Orenburg

ZIP/Postal Code

460000

Country

Russian Federation

Facility Name

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

City

Saint Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

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

City

Saint Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

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

City

Saint Petersburg

ZIP/Postal Code

197046

Country

Russian Federation

Facility Name

Saint Petersburg State Healthcare Institution "Aleksandrovskaya Hospital"

City

Saint-Petersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

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

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

Cherkasska Regional Hospital. Department of Orthopedics and Traumatology.

City

Cherkassy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

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

City

Ivano-Frankivsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Odessa Regional Clinical Hospital, Department of Orthopedics and Traumatology

City

Odessa

ZIP/Postal Code

65025

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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