Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery

August 22, 2012 updated by: ThromboGenics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
632

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
        • KRANKENHAUS DES BARMHER.SCHW.Linz
      • Wels, Austria
        • Klinikum Wels-Grieskirchen GmbH
      • Wien, Austria
        • AKH Wien
      • Wien, Austria
        • Orthopädisches Spital Speising
  • Belgium
      • Antwerpen, Belgium
        • ZNA Antwerpen Locatie Middelheim
  • Bulgaria
      • Pleven, Bulgaria
        • SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology
      • Plovdiv, Bulgaria
        • Department of Orthopedics, UMHAT "Sv. Georgi"
      • Rousse, Bulgaria
        • MHAT Rousse, Department of Orthopaedics
      • Sofia, Bulgaria
        • UMHAT "St Anna" AD,Clinic of Orthopaedics and Traumatology
      • Sofia, Bulgaria
        • UMHAT 'Tsaritsa Joanna'
  • Hungary
      • Gyula, Hungary
        • Pandy Kalman Korhaz
      • Kecskemét, Hungary
        • Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi Tudományegyetem Általános Orvostudományi Karháza
      • Szekszárd, Hungary
        • Tolna Megyei Önkormányzat Balassa János Kórháza
  • Latvia
      • Adazi, Latvia
        • Traumatology and Orthopedics Clinic "Adazi", LTD
      • Liepāja, Latvia
        • Ltd "Liepajas regionala slimnica"
      • Riga, Latvia
        • Riga 2nd Hospital
      • Valmiera, Latvia
        • Ltd "Vidzemes slimnica"
  • Netherlands
      • Leiden, Netherlands
        • Diaconessenhuis Leiden
  • Poland
      • Bialystok, Poland
        • Klinika Orthopedii I Traumatologii
      • Puszczykowo, Poland
        • NZOZ Szpital w Puszczykowie
      • Warsaw, Poland
        • Medical University of warsaw, Dept of Orthopaedics
      • Warszawa, Poland
        • Klinika Ortopedii, WIM
      • Łódź, Poland
        • Wojewódzkie Centrum Ortopedii i Rehabilitacji Narządu Ruchu im. dr Z. Radlińskiego w Łodzi
  • Russian Federation
      • Chelabinsk, Russian Federation
        • Municipal Healthcare Institution "City Clinical Hospital No. 3"
      • Orenburg, Russian Federation
        • Municipal Healthcare Medical Institution "City Clinical Hospital No. 4"
      • Saint-Petersburg, Russian Federation
        • Federal State Healthcare Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency of Russia
      • Saint-Petersburg, Russian Federation
        • Saint Petersburg State Healthcare Institution "City Aleksandrovskaya Hospital"
      • Saint-Petersburg, Russian Federation
        • Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2"
      • Samara, Russian Federation
        • State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
      • Yaroslavl, Russian Federation
        • Municipal Healthcare Institution "Clinical Hospital of Emergency Care n.a. N.V. Soloviov"
  • Ukraine
      • Cherkassy, Ukraine
        • Public Entity "Regional Hospital - Center of Emergency Medical Care and Disaster Medicine" of Cherkasy Regional Council, Department of orthopedy and traumatology
      • Ivano-Frankivsk, Ukraine
        • 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
      • Kharkiv, Ukraine
        • SE "Sytenko Institute of Spine and Joint Pathology, AMS Ukraine", department of orthopedic arthrology and endoprosthesis replacement
      • Kyiv, Ukraine
        • 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"
      • Odessa, Ukraine
        • Public Establishment "Odessa Regional Clinical Hospital", Department of Orthopedics and Traumatology.
      • Sevastopol, Ukraine
        • Public Establishment 'City Hospital #9', orthopedy and traumatology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects aged ≥ 18 years.
  2. Written informed consent.
  3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

Exclusion Criteria:

  1. Pregnancy at the time of screening.
  2. Indication for anticoagulation other than post-operative thromboprophylaxis.
  3. Active bleeding or high risk of bleeding.
  4. Anticipated continued use of neuraxial catheter after surgery.
  5. Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT.
  6. Uncontrolled hypertension.
  7. Impaired liver function (transaminase >3 X ULN) or history of hepatic insufficiency.
  8. Creatinine clearance <30 mL/min.
  9. Antiplatelet agents other than low dose aspirin (< 200mg).
  10. The use of intermittent pneumatic compression.
  11. Known hypersensitivity to contrast media or rivaroxaban.
  12. Known drug or alcohol abuse.
  13. Active malignant disease or current cytostatic treatment.
  14. Stroke within the previous month.
  15. Participation in an investigational drug study within the past 30 days or previous participation in this study.
  16. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 25mg TB-402
Drug: TB-402
Administered intravenously over 10 minutes
Experimental: 50mg TB-402
Drug: TB-402
Administered intravenously over 10 minutes
Active Comparator: 10mg QD Rivaroxaban
Drug: Rivaroxaban
Administered orally as a capsule once a day for 35 days
Other Names:
  • Xarelto

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Randomisation to post-operative day 35

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidents of major VTE
Time Frame: Randomisation to Post-Operative day 35
Randomisation to Post-Operative day 35
Incidents of total DVT
Time Frame: Randomisation to Post-Operative day 35
Randomisation to Post-Operative day 35
Incidents of proximal/distal DVT
Time Frame: Randomisation to Post-Operative day 35
Randomisation to Post-Operative day 35
Incidents of pulmonary embolism
Time Frame: Randomisation to Post-Operative day 35
Randomisation to Post-Operative day 35
Incidents of VTE-related death
Time Frame: Randomisation to Post-Operative day 35
Randomisation to Post-Operative day 35
Incidents of Major VTE
Time Frame: Randomisation to Post-Operative day 70
Randomisation to Post-Operative day 70

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ThromboGenics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BioInvent International AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TB-402-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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