Prophylaxis of Venous Thromboembolic EventsPhase 2NCT01344954
Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery
A Phase 2 study testing TB-402 and Rivaroxaban in people with Prophylaxis of Venous Thromboembolic Events, run by ThromboGenics at 36 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prophylaxis of Venous Thromboembolic Events
- What is being tested?
- TB-402 and Rivaroxaban
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 36 sitesin 9 countries
- Study dates
- Apr 2011to May 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥ 18 years.
- Written informed consent.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Who cannot join
- Pregnancy at the time of screening.
- Indication for anticoagulation other than post-operative thromboprophylaxis.
- Active bleeding or high risk of bleeding.
- Anticipated continued use of neuraxial catheter after surgery.
- Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT.
- Uncontrolled hypertension.
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- Impaired liver function (transaminase >3 X ULN) or history of hepatic insufficiency.
- Creatinine clearance <30 mL/min.
- Antiplatelet agents other than low dose aspirin (< 200mg).
- The use of intermittent pneumatic compression.
- Known hypersensitivity to contrast media or rivaroxaban.
- Known drug or alcohol abuse.
- Active malignant disease or current cytostatic treatment.
- Stroke within the previous month.
- Participation in an investigational drug study within the past 30 days or previous participation in this study.
- Any condition that in the opinion of the investigator would put the subject at increased risk from participating in the study or expected inability to comply with the protocol.
Trial locations and contacts
36 sites in 9 countries.
36 sites in 9 countries
Russia7 sites
Municipal Healthcare Institution "City Clinical Hospital No. 3"
Chelabinsk
Municipal Healthcare Medical Institution "City Clinical Hospital No. 4"
Orenburg
Federal State Healthcare Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency of Russia
Saint Petersburg
Saint Petersburg State Healthcare Institution "City Aleksandrovskaya Hospital"
Saint Petersburg
Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2"
Saint Petersburg
State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
Samara
Municipal Healthcare Institution "Clinical Hospital of Emergency Care n.a. N.V. Soloviov"
Yaroslavl
Ukraine6 sites
Public Entity "Regional Hospital - Center of Emergency Medical Care and Disaster Medicine" of Cherkasy Regional Council, Department of orthopedy and traumatology
Cherkassy
Ivano-Frankіvsk Regional Clinical Hospital MoH Ukraine, Department of ortopedics and traumatology. Department of traumatology, ortopedics and military/emergency surgery of Ivano-Frankіvsk National Medical University
Ivano-Frankivsk
SE "Sytenko Institute of Spine and Joint Pathology, AMS Ukraine", department of orthopedic arthrology and endoprosthesis replacement
Kharkiv
Public Entity of Kyiv Regional council "Kyiv Regional Clinical Hospital", Ortopedy and traumatology center of Public Entity of Kyiv Regional council "Kyiv Regional Clinical Hospital"
Kyiv
Public Establishment "Odessa Regional Clinical Hospital", Department of Orthopedics and Traumatology.
Odesa
Public Establishment 'City Hospital #9', orthopedy and traumatology department
Sevastopol
Bulgaria5 sites
SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology
Pleven
Department of Orthopedics, UMHAT "Sv. Georgi"
Plovdiv
MHAT Rousse, Department of Orthopaedics
Rousse
UMHAT "St Anna" AD,Clinic of Orthopaedics and Traumatology
Sofia
UMHAT 'Tsaritsa Joanna'
Sofia
Poland5 sites
Klinika Orthopedii I Traumatologii
Bialystok
Wojewódzkie Centrum Ortopedii i Rehabilitacji Narządu Ruchu im. dr Z. Radlińskiego w Łodzi
Lodz
NZOZ Szpital w Puszczykowie
Puszczykowo
Klinika Ortopedii, WIM
Warsaw
Medical University of warsaw, Dept of Orthopaedics
Warsaw
Austria4 sites
KRANKENHAUS DES BARMHER.SCHW.Linz
Linz
AKH Wien
Vienna
Orthopädisches Spital Speising
Vienna
Klinikum Wels-Grieskirchen GmbH
Wels
Latvia4 sites
Traumatology and Orthopedics Clinic "Adazi", LTD
Adazi
Ltd "Liepajas regionala slimnica"
Liepāja
Riga 2nd Hospital
Riga
Ltd "Vidzemes slimnica"
Valmiera
Hungary3 sites
Pándy Kálmán Kórház
Gyula
Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi Tudományegyetem Általános Orvostudományi Karháza
Kecskemét
Tolna Megyei Önkormányzat Balassa János Kórháza
Szekszárd
About this study
Official title: Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery: A Phase 2b, Multicentre, Randomised, Active-Controlled, Double Blind, Double Dummy, Parallel Group Study
The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.
- Being tested
- TB-402, Rivaroxaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB-402Drug
Administered intravenously over 10 minutes
RivaroxabanDrug
Also called Xarelto
Administered orally as a capsule once a day for 35 days
TB-402Drug
Administered intravenously over 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| 25mg TB-402 | Experimental | Not described Receives: Drug: TB-402 |
| 50mg TB-402 | Experimental | Not described Receives: Drug: TB-402 |
| 10mg QD Rivaroxaban | Active comparator | Not described Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE
Measured: Randomisation to post-operative day 35
Secondary outcomes (6)
Incidents of major VTE
Measured: Randomisation to Post-Operative day 35
Incidents of total DVT
Measured: Randomisation to Post-Operative day 35
Incidents of proximal/distal DVT
Measured: Randomisation to Post-Operative day 35
Incidents of pulmonary embolism
Measured: Randomisation to Post-Operative day 35
Incidents of VTE-related death
Measured: Randomisation to Post-Operative day 35
Incidents of Major VTE
Measured: Randomisation to Post-Operative day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prophylaxis of Venous Thromboembolic EventsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 632 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioInvent International AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344954
- Sponsor's protocol ID
- TB-402-006
- Status last verified
- Aug 2012
- First submitted
- 18 Mar 2011
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. 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 Hip Replacement Surgery: A Phase 2b, Multicentre, Randomised, Active-Controlled, Double Blind, Double Dummy, Parallel Group Study
- ClinicalTrials.gov ID
- NCT01344954
- Acronym / sponsor ID
- TB-402-006
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 632 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Collaborators
- BioInvent International AB
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Apr 2011 (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 two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 25mg TB-402 | Experimental | Drug: TB-402 |
| 50mg TB-402 | Experimental | Drug: TB-402 |
| 10mg QD Rivaroxaban | Active comparator | Drug: Rivaroxaban |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects aged ≥ 18 years.
- Written informed consent.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Key exclusion criteria (16 listed)
- Pregnancy at the time of screening.
- Indication for anticoagulation other than post-operative thromboprophylaxis.
- Active bleeding or high risk of bleeding.
- Anticipated continued use of neuraxial catheter after surgery.
- Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT.
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-402Administered intravenously over 10 minutes | Drug | 25mg TB-402 |
| RivaroxabanAlso: XareltoAdministered orally as a capsule once a day for 35 days | Drug | 10mg QD Rivaroxaban |
| TB-402Administered intravenously over 10 minutes | Drug | 50mg TB-402 |
Primary outcome
Composite of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE
Time frame: Randomisation to post-operative day 35
6 secondary outcomes
Incidents of major VTE
Time frame: Randomisation to Post-Operative day 35
Incidents of total DVT
Time frame: Randomisation to Post-Operative day 35
Incidents of proximal/distal DVT
Time frame: Randomisation to Post-Operative day 35
Incidents of pulmonary embolism
Time frame: Randomisation to Post-Operative day 35
Incidents of VTE-related death
Time frame: Randomisation to Post-Operative day 35
Incidents of Major VTE
Time frame: Randomisation to Post-Operative day 70
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 23 Aug 2012.
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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.
36 sites in 9 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 Rivaroxaban in people with Prophylaxis of Venous Thromboembolic Events, run by ThromboGenics at 36 sites in 9 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 3 inclusion and 16 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 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Russia, Ukraine, Bulgaria, Poland, Austria and 4 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?
Composite of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE (time frame: Randomisation to post-operative day 35). 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 23 Aug 2012.