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

Primary Purpose

Prophylaxis of Venous Thromboembolic Events

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TB-402
Rivaroxaban
TB-402
Sponsored by
ThromboGenics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prophylaxis of Venous Thromboembolic Events

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

25mg TB-402

50mg TB-402

10mg QD Rivaroxaban

Arm Description

Outcomes

Primary Outcome Measures

Composite of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE

Secondary Outcome Measures

Incidents of major VTE
Incidents of total DVT
Incidents of proximal/distal DVT
Incidents of pulmonary embolism
Incidents of VTE-related death
Incidents of Major VTE

Full Information

First Posted
March 18, 2011
Last Updated
August 22, 2012
Sponsor
ThromboGenics
Collaborators
BioInvent International AB
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1. Study Identification

Unique Protocol Identification Number
NCT01344954
Brief Title
Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ThromboGenics
Collaborators
BioInvent International AB

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prophylaxis of Venous Thromboembolic Events

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
632 (Actual)

8. Arms, Groups, and Interventions

Arm Title
25mg TB-402
Arm Type
Experimental
Arm Title
50mg TB-402
Arm Type
Experimental
Arm Title
10mg QD Rivaroxaban
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
TB-402
Intervention Description
Administered intravenously over 10 minutes
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
Xarelto
Intervention Description
Administered orally as a capsule once a day for 35 days
Intervention Type
Drug
Intervention Name(s)
TB-402
Intervention Description
Administered intravenously over 10 minutes
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Incidents of major VTE
Time Frame
Randomisation to Post-Operative day 35
Title
Incidents of total DVT
Time Frame
Randomisation to Post-Operative day 35
Title
Incidents of proximal/distal DVT
Time Frame
Randomisation to Post-Operative day 35
Title
Incidents of pulmonary embolism
Time Frame
Randomisation to Post-Operative day 35
Title
Incidents of VTE-related death
Time Frame
Randomisation to Post-Operative day 35
Title
Incidents of Major VTE
Time Frame
Randomisation to Post-Operative day 70

10. Eligibility

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

12. IPD Sharing Statement

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

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