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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00793234
Other study ID # TB-402-004
Secondary ID
Status Completed
Phase Phase 2
First received November 18, 2008
Last updated April 4, 2014
Start date December 2008
Est. completion date March 2010

Study information

Verified date April 2014
Source ThromboGenics
Contact n/a
Is FDA regulated No
Health authority Russia: Pharmacological Committee, Ministry of HealthLatvia: State Agency of MedicinesIsrael: Ministry of HealthRomania: Ministry of Public HealthBulgaria: Ministry of HealthPoland: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 316
Est. completion date March 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
TB-402
TB-402 administered as single bolus 18-24 post total knee replacement surgery.
Enoxaparin
Enoxaparin 40mg/day sc injection for at least 10 days post-surgery

Locations

Country Name City State
Bulgaria 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
Israel 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 Beilinson Hospital Petach Tikva
Israel Kaplan MC Rehovot
Israel Sourasky MC Tel Aviv
Latvia Ltd "Liepajas regionala slimnica" Liepaja
Latvia Ltd "Traumatologijas un ortopedijas slimnica" Riga
Latvia Vidzemes slimnica Valmiera
Poland Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy Klinika Ortopedii i Traumatologii Narzadu Ruchu Bydgoszcz
Poland Wojewódzki Szpital Specjalistyczny im. L. Rydygiera w Krakowie, Oddzial Kliniczny Ortopedii i Traumatologii Narzadu Ruchu Kraków
Poland Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Katedra i Klinika Ortopedii Traumatologii i Rehabilitacji Lubuskie
Poland Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Ortopedii i Traumatologii Podlaski
Poland Wojewódzki Szpital Bródnowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Oddzial Chirurgii Urazowo-Ortopedycznej i Rehabilitacji Warszawa
Romania Spitalul Clinic de Urgenta Sf. Ioan Bucuresti Bucuresti
Romania Spitalul Clinic de Urgenta Prof. Dr. Octavian Fodor CLUJ NAPOCA Cluj - Napoca
Romania Spitalul Clinic Judetean de Urgenta Craiova Craiova
Russian Federation Municipal Healthcare Institution "City Clinical Hospital No. 3" Cheliabinsk
Russian Federation Moscow State Healthcare Institution "City Clinical Hospital No. 15 n.a. O.M. Filatov" Moscow
Russian Federation Municipal Healthcare Institution "City Clinical Hospital No. 4" Orenburg
Russian Federation 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
Russian Federation Federal State Medical Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency Saint Petersburg
Russian Federation Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2" Saint Petersburg
Russian Federation Saint Petersburg State Healthcare Institution "Aleksandrovskaya Hospital" Saint-Petersburg
Russian Federation State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin" Samara
Ukraine Cherkasska Regional Hospital. Department of Orthopedics and Traumatology. Cherkassy
Ukraine Ivano-Frank?vsk Regional Clinical Hospital, Department of ortopedics and traumatology. Ivano-Frankivsk
Ukraine Odessa Regional Clinical Hospital, Department of Orthopedics and Traumatology Odessa

Sponsors (3)

Lead Sponsor Collaborator
ThromboGenics BioInvent International AB, Covance

Countries where clinical trial is conducted

Bulgaria,  Israel,  Latvia,  Poland,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Primary 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 No
Secondary Incidence of major bleeding events All visists from randomization to end of study Yes
Secondary Incidence of clinically significant non-major bleeding events All visits from randomization to end of study Yes
Secondary Incidence of minor bleeding events All visits from randomization to end of study Yes
Secondary Incidence of all cause mortality All visits from randomization to end of study Yes
Secondary Incidence of adverse events All visists from randomization to end of study Yes
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