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

NCT01344954 | Completed Phase 2 DMC

• 1 other identifier: TB-402-006
• Study Type: interventional
• Target: 632
• Locations: 9 countries
• Sites: 36

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.

Conditions

Prophylaxis of Venous Thromboembolic Events

Outcome Measures

Primary Outcomes (1)

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

  Randomisation to post-operative day 35

Secondary Outcomes (6)

• Incidents of major VTE

  Randomisation to Post-Operative day 35

• Incidents of total DVT

  Randomisation to Post-Operative day 35

• Incidents of proximal/distal DVT

  Randomisation to Post-Operative day 35

• Incidents of pulmonary embolism

  Randomisation to Post-Operative day 35

• Incidents of VTE-related death

  Randomisation to Post-Operative day 35

Study Arms (3)

25mg TB-402

EXPERIMENTAL

Drug: TB-402

50mg TB-402

EXPERIMENTAL

Drug: TB-402

10mg QD Rivaroxaban

ACTIVE COMPARATOR

Drug: Rivaroxaban

Interventions

TB-402 DRUG

Administered intravenously over 10 minutes

25mg TB-402

Rivaroxaban DRUG

Administered orally as a capsule once a day for 35 days

Also known as: Xarelto

10mg QD Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ThromboGenics: lead
• BioInvent International AB: collaborator

Study Sites (36)

KRANKENHAUS DES BARMHER.SCHW.Linz

Linz, Austria

Location

AKH Wien

Vienna, Austria

Location

Orthopädisches Spital Speising

Vienna, Austria

Location

Klinikum Wels-Grieskirchen GmbH

Wels, Austria

Location

ZNA Antwerpen Locatie Middelheim

Antwerp, Belgium

Location

SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology

Pleven, Bulgaria

Location

Department of Orthopedics, UMHAT "Sv. Georgi"

Plovdiv, Bulgaria

Location

MHAT Rousse, Department of Orthopaedics

Rousse, Bulgaria

Location

UMHAT "St Anna" AD,Clinic of Orthopaedics and Traumatology

Sofia, Bulgaria

Location

UMHAT 'Tsaritsa Joanna'

Sofia, Bulgaria

Location

Pándy Kálmán Kórház

Gyula, Hungary

Location

Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi Tudományegyetem Általános Orvostudományi Karháza

Kecskemét, Hungary

Location

Tolna Megyei Önkormányzat Balassa János Kórháza

Szekszárd, Hungary

Location

Traumatology and Orthopedics Clinic "Adazi", LTD

Ādaži, Latvia

Location

Ltd "Liepajas regionala slimnica"

Liepāja, Latvia

Location

Riga 2nd Hospital

Riga, Latvia

Location

Ltd "Vidzemes slimnica"

Valmiera, Latvia

Location

Diaconessenhuis Leiden

Leiden, Netherlands

Location

Klinika Orthopedii I Traumatologii

Bialystok, Poland

Location

Wojewódzkie Centrum Ortopedii i Rehabilitacji Narządu Ruchu im. dr Z. Radlińskiego w Łodzi

Lodz, Poland

Location

NZOZ Szpital w Puszczykowie

Puszczykowo, Poland

Location

Klinika Ortopedii, WIM

Warsaw, Poland

Location

Medical University of warsaw, Dept of Orthopaedics

Warsaw, Poland

Location

Municipal Healthcare Institution "City Clinical Hospital No. 3"

Chelabinsk, Russia

Location

Municipal Healthcare Medical Institution "City Clinical Hospital No. 4"

Orenburg, Russia

Location

Federal State Healthcare Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency of Russia

Saint Petersburg, Russia

Location

Saint Petersburg State Healthcare Institution "City Aleksandrovskaya Hospital"

Saint Petersburg, Russia

Location

Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2"

Saint Petersburg, Russia

Location

State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin"

Samara, Russia

Location

Municipal Healthcare Institution "Clinical Hospital of Emergency Care n.a. N.V. Soloviov"

Yaroslavl, Russia

Location

Public Entity "Regional Hospital - Center of Emergency Medical Care and Disaster Medicine" of Cherkasy Regional Council, Department of orthopedy and traumatology

Cherkassy, Ukraine

Location

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, Ukraine

Location

SE "Sytenko Institute of Spine and Joint Pathology, AMS Ukraine", department of orthopedic arthrology and endoprosthesis replacement

Kharkiv, Ukraine

Location

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, Ukraine

Location

Public Establishment "Odessa Regional Clinical Hospital", Department of Orthopedics and Traumatology.

Odesa, Ukraine

Location

Public Establishment 'City Hospital #9', orthopedy and traumatology department

Sevastopol, Ukraine

Location

MeSH Terms

Interventions

TB 402; Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: April 29, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2012
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

BU (5); RU (7); UA (6); BE (1); LA (4); PL (5); AU (4); NL (1); HU (3)