Total Knee Replacement SurgeryPhase 2NCT00793234
Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery
A Phase 2 study testing TB-402 and Enoxaparin in people with Total Knee Replacement Surgery, run by ThromboGenics at 35 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Replacement Surgery
- What is being tested?
- TB-402 and Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 35 sitesin 7 countries
- Study dates
- Dec 2008to Mar 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
35 sites in 7 countries.
35 sites in 7 countries
Israel8 sites
Asaf Harofeh MC
Beer-Yaakov, 70300
Soroka MC
Beersheba, 84101
Rambam MC
Haifa, 31096
Shaare Zedek MC
Jerusalem, 91031
Meir Medical Center (MC)
Kfar Saba, 44281
Beilinson Hospital
Petah Tikva, 49100
Kaplan MC
Rehovot, 76100
Sourasky MC
Tel Aviv, 64239
Russia8 sites
Municipal Healthcare Institution "City Clinical Hospital No. 3"
Chelyabinsk, 454136
Moscow State Healthcare Institution "City Clinical Hospital No. 15 n.a. O.M. Filatov"
Moscow, 111539
Municipal Healthcare Institution "City Clinical Hospital No. 4"
Orenburg, 460000
Saint Petersburg State Healthcare Institution "Aleksandrovskaya Hospital"
Saint Petersburg, 193312
Federal State Medical Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency
Saint Petersburg, 194291
Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2"
Saint Petersburg, 194354
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
State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
Samara, 443095
Bulgaria5 sites
SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology
Pleven, 5800
Dept. of Orthopedics, UMHAT "Saint George"
Plovdiv, 4002
MHAT Rousse
Rousse, 7002
MHAT "Sveta Anna" AD - Sofia, Clinic of Orthopedics and Traumatology
Sofia, 1709
MHAT "Sv. Anna", Department of Orthopaedics and Traumatology
Varna, 9000
Poland5 sites
Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy Klinika Ortopedii i Traumatologii Narządu Ruchu
Bydgoszcz, 85-094
Wojewódzki Szpital Specjalistyczny im. L. Rydygiera w Krakowie, Oddział Kliniczny Ortopedii i Traumatologii Narządu Ruchu
Krakow, 31-826
Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Ortopedii i Traumatologii
Podlaski, 15-276
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Katedra i Klinika Ortopedii Traumatologii i Rehabilitacji
Trzemeszno Lubuskie, 20-090
Wojewódzki Szpital Bródnowski Samodzielny Publiczny Zakład Opieki Zdrowotnej, Oddział Chirurgii Urazowo-Ortopedycznej i Rehabilitacji
Warsaw, 03-242
Latvia3 sites
Ltd "Liepajas regionala slimnica"
Liepāja, LV-3400
Ltd "Traumatologijas un ortopedijas slimnica"
Riga, LV-1005
Vidzemes slimnica
Valmiera, LV 4201
Romania3 sites
Spitalul Clinic de Urgenta Sf. Ioan Bucuresti
Bucharest, 042122
Spitalul Clinic de Urgenta Prof. Dr. Octavian Fodor CLUJ NAPOCA
Cluj-Napoca, 400132
Spitalul Clinic Judetean de Urgenta Craiova
Craiova, 200642
Ukraine3 sites
Cherkasska Regional Hospital. Department of Orthopedics and Traumatology.
Cherkassy, 18009
Ivano-Frankіvsk Regional Clinical Hospital, Department of ortopedics and traumatology.
Ivano-Frankivsk, 76008
Odessa Regional Clinical Hospital, Department of Orthopedics and Traumatology
Odesa, 65025
About this study
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
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.
Read the 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.
- Conditions
- Total Knee Replacement Surgery
- Being tested
- TB-402, Enoxaparin
- Keywords
- TKR, VTE, DVT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB-402Drug
TB-402 administered as single bolus 18-24 post total knee replacement surgery.
EnoxaparinDrug
Enoxaparin 40mg/day sc injection for at least 10 days post-surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 0.3 mg/kg TB-402 Receives: Drug: TB-402 |
| 2 | Experimental | 0.6 mg/kg TB-402 Receives: Drug: TB-402 |
| 3 | Experimental | 1.2 mg/kg TB-402 Receives: Drug: TB-402 |
| 4 | Active comparator | Not described Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of total bleeding defined as major and/or clinically relevant non-major bleeding events, from randomisation until the end of the study.
Measured: 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.
Measured: Prior to hospital discharge Day 7-11
Secondary outcomes (5)
Incidence of major bleeding events
Measured: All visists from randomization to end of study
Incidence of clinically significant non-major bleeding events
Measured: All visits from randomization to end of study
Incidence of minor bleeding events
Measured: All visits from randomization to end of study
Incidence of all cause mortality
Measured: All visits from randomization to end of study
Incidence of adverse events
Measured: All visists from randomization to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Replacement SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioInvent International AB, Covance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793234
- Sponsor's protocol ID
- TB-402-004
- Status last verified
- Apr 2014
- First submitted
- 18 Nov 2008
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00793234
- Acronym / sponsor ID
- TB-402-004
- Conditions
- Total Knee Replacement Surgery
- Keywords
- TKR, VTE, DVT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Collaborators
- BioInvent International AB, Covance
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TB-4020.3 mg/kg TB-402 |
| 2 | Experimental | Drug: TB-4020.6 mg/kg TB-402 |
| 3 | Experimental | Drug: TB-4021.2 mg/kg TB-402 |
| 4 | Active comparator | Drug: Enoxaparin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TB-402TB-402 administered as single bolus 18-24 post total knee replacement surgery. | Drug | 1, 2, 3 |
| EnoxaparinEnoxaparin 40mg/day sc injection for at least 10 days post-surgery | Drug | 4 |
Primary outcome
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
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
5 secondary outcomes
Incidence of major bleeding events
Time frame: All visists from randomization to end of study
Incidence of clinically significant non-major bleeding events
Time frame: All visits from randomization to end of study
Incidence of minor bleeding events
Time frame: All visits from randomization to end of study
Incidence of all cause mortality
Time frame: All visits from randomization to end of study
Incidence of adverse events
Time frame: All visists from randomization to end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TB-402 and Enoxaparin in people with Total Knee Replacement Surgery, run by ThromboGenics at 35 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Israel, Russia, Bulgaria, Poland, Latvia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2014.