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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03891524
Other study ID # CR108600
Secondary ID 70033093THR20012
Status Completed
Phase Phase 2
First received
Last updated
Start date June 17, 2019
Est. completion date April 6, 2021

Study information

Verified date July 2022
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy of JNJ-70033093 in preventing total venous thromboembolism (VTE) events (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death) during the treatment period.


Description:

JNJ-70033093 is an oral anticoagulant for prevention and treatment of thromboembolic events (for example, VTE) that binds and inhibits activated form of human coagulation Factor XI (FXIa) with high affinity and selectivity. The study will consist of 3 phases: up to 30-day screening phase before total knee replacement (TKR) surgery, 10 to14 day postoperative dosing phase, and 4-week follow-up phase. The hypothesis of this study is JNJ-70033093 reduces risk of total VTE during treatment period. The total duration of participation following randomization will be approximately 6 weeks. Efficacy evaluations include unilateral venography assessment of operated leg and assessments of symptomatic DVT, PE, or death. Safety evaluation includes adverse events, clinical laboratory tests, and physical examinations. The safety and efficacy will be monitored throughout the study.


Recruitment information / eligibility

Status Completed
Enrollment 1242
Est. completion date April 6, 2021
Est. primary completion date April 6, 2021
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Medically stable and appropriate for anticoagulant prophylaxis as determined by the investigator on the basis of physical examination, medical history, and vital signs performed as part of screening for elective total knee replacement (TKR) surgery - Medically stable and appropriate for anticoagulant prophylaxis on the basis of clinical laboratory tests performed as part of local standard-of-care as part of screening for elective TKR surgery - Has plans to undergo an elective primary unilateral TKR surgery - A woman must be- a) Not of childbearing potential; b) Of childbearing potential and practicing a highly effective method of contraception (failure rate of less than [<]1 percent [%] per year when used consistently and correctly) and agrees to remain on a highly effective method for the duration of study drug with JNJ-70033093 plus 5 half-lives of study drug plus 30 days (duration of ovulatory cycle) for a total of 34 days after the completion of treatment, pregnancy testing (serum or urine) prior to the first dose of study drug - Willing and able to adhere to the lifestyle restrictions specified in this protocol Exclusion Criteria: - History of any condition for which the use of low molecular-weight heparin (LMWH) is not recommended in the opinion of the investigator (for example, previous allergic reaction, creatinine clearance <30 milliliter per minute [mL/minute]) - History of severe hepatic impairment - Planned bilateral revision or unicompartmental procedure - Unable to undergo venography (for example, due to contrast agent allergy, poor venous access, or impaired renal function that would increase the risk of contrast-induced nephropathy - Known previous pulmonary embolism (PE) or deep vein thrombosis (DVT) in either lower extremity

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
JNJ-70033093 25 mg
Participants will receive JNJ-70033093 25 mg (1*25 mg capsule) BID (in Group A) or once daily (in Group E), orally for 10 to 14 postoperative days.
JNJ-70033093 50 mg
Participants will receive JNJ-70033093 50 mg (2*25 mg capsules) BID orally for 10 to 14 postoperative days.
JNJ-70033093 100 mg
Participants will receive JNJ-70033093 100 mg (1*100 mg capsule) BID, orally for 10 to 14 postoperative days.
JNJ-70033093 200 mg
Participants will receive JNJ-70033093 200 mg (2*100 mg capsules) BID (in Group D) or once daily (in Group F), orally for 10 to 14 postoperative days.
Placebo
Participants will receive placebo matching to JNJ-70033093, orally.
Enoxaparin 40 mg
Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.

Locations

Country Name City State
Argentina Clínica Adventista Belgrano Caba
Argentina Hospital Britanico de Buenos Aires Ciudad Autonoma de Buenos Aires
Argentina Clínica Chutro Córdoba
Argentina Hospital San Roque Córdoba
Argentina Hospital Italiano La Plata La Plata
Argentina Instituto de Investigaciones Clinicas Rosario Rosario
Argentina Sanatorio Corporación Médica de General San Martín San Martín
Belgium ZNA Middelheim Antwerpen
Belgium Ziekenhuis Oost-Limburg Genk
Belgium Jessa Ziekenhuis Hasselt
Belgium ZNA Jan Palfijn Merksem
Brazil Hospital Sao Francisco de Assis Belo Horizonte
Brazil Hospital e Maternidade Dr Christovão da Gama Santo André
Brazil Hospital Estadual Mario covas Santo André
Bulgaria University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski Pleven
Bulgaria Acibadem City Clinic Tokuda Hospital Sofa
Bulgaria MHAT Tzaritza Joanna Sofia
Bulgaria University Multiprofile Hospital Sofiamed Sofia Sofia
Bulgaria Medical Center - Medical Complex BEROE EOOD Stara Zagora
Canada Lakeridge Health Ajax Ontario
Canada Hamilton Health Sciences Corporation Hamilton Ontario
Canada The Ottawa Hospital Research Institute Ottawa Ontario
Canada Medical Investigative and Clinical Evaluation Inc Windsor Ontario
Greece General Hospital of Attiki 'KAT' Kifisia
Greece General Hospital of Nea Ionia 'Konstantopoulio' Nea Ionia
Greece University General Hospital of Rio Patras Patra
Greece Papageorgiou General Hospital Thessaloniki
Hungary Semmelweis Egyetem Budapest
Hungary Debreceni Egyetem Debrecen
Hungary Petz Aladar Megyei Oktato Korhaz Gyõr
Hungary Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvar
Hungary Bacs-kiskun Megyei Korhaz Kecskemét
Hungary Szegedi Tudomanyegyetem Szeged
Hungary Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz Szekesfehervar
Hungary MAV Korhaz es Rendelointezet Szolnok
Israel Carmel Medical Center Haifa
Israel Rambam Medical Center Haifa
Israel Meir Medical Center Kfar Saba
Israel Kaplan Medical Center Rehovot
Italy Azienda Ospedaliera Papa Giovanni XXIII Bergamo
Italy Cliniche Humanitas Gavazzeni Bergamo
Italy Istituto Ortopedico Rizzoli Bologna
Italy Policlinico S. Matteo Pavia
Italy Istituto Clinico Humanitas Rozzano
Italy A.O.U. Città della Salute e della Scienza Torino
Japan Matsudo City General Hospital Chiba
Japan Hakodate Goryokaku Hospital Hakodate
Japan Japanese Red Cross Hamamatsu Hospital Hamamatsu
Japan Itami City Hospital Itami-shi
Japan Yonemori Hospital Kagoshima-shi
Japan Japan Community Health care Organization Kyushu Hospital Kitakyushu-shi,
Japan Marunouchi Hospital Matsumoto
Japan Chubu Rosai Hospital Nagoya
Japan Juntendo University Nerima Hospital Nerima-Ku
Japan National Hospital Organization Okayama Medical Center Okayama
Japan Yuuai Medical Center Okinawa, Tomigusuku-shi
Japan Japan Community Health Care Organization Saitama Medical Center Saitama
Japan Saitama City Hospital Saitama-shi
Japan Nagano Prefectural Shinshu Medical Center Suzaka
Japan Juntendo University Hospital Tokyo
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bielsku Podlaskim,Oddzial Urazowo-Ortopedyczny Bielsk Podlaski
Poland Szpital Ogolny im. W. Ginela, Oddzial Urazowo-Ortopedyczny Grajewo
Poland Wojewodzki Szpital Zespolony w Kielcach, Klinika Chirurgii Ortopedyczno-Urazowej Kielce
Poland Oddzial Ortopedii i Traumatologii Narzadu Ruchu Szpital Specjalistyczny im. Ludwika Rydygiera Krakow
Poland CSK UM Klinika Ortopedii Lodz
Poland Oddzial Urazowo-Ortopedyczny Wojewodzki Szpital Specjalistyczny Lublin
Poland Oddzial Ortopedii Specjalistyczny Szpital im. E.Szczeklika Tarnow
Poland Oddzial Chirurgii Urazowej iOrtopedycznej,Wojewodzki Szpital Brodnowski, SPZOZ Warszawa
Poland Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw
Portugal Centro Hospitalar do Baixo Vouga - Hospital Infante Dom Pedro Aveiro
Portugal Hosp. de Cascais Cascais
Portugal H. Santo António - Centro Hospitalar do Porto Porto
Portugal CHS - Hosp. Orto. Sant'Iago do Outao Setubal
Portugal ULSAM, EPE - Hospital de Santa Luzia Viana do Castelo
Russian Federation National Medical Research Center of Traumatology and Orthopaedics n.a. G.A. Ilizarov Kurgan
Russian Federation Private Healthcare Institution 'Clinical Hospital 'RZD-Medcine' n.a. N.A.Semashko' Moscow
Russian Federation Privolzhsky Regional Medical Center of Federal Medical and Biological Agency Nizhniy Novgorod
Russian Federation National medical research center of Traumatology and Orthopaedics n.a. R.R.Vreden Saint-Petersburg
Russian Federation State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin Samara
Russian Federation Smolensk Federal Center of Traumatology, Orthopedics and Endoprothesis Replacement Smolensk
Russian Federation Sochi City Hospital #4 Sochi
South Africa Steve Biko Academic Hospital Pretoria
South Africa Clinical Project Research SA Worcester
Spain Hosp. Univ. Fundacion Alcorcon Alcorcón
Spain Hosp. Univ. Germans Trias I Pujol Badalona
Spain Hosp. Clinic I Provincial de Barcelona Barcelona
Spain Hosp. Univ. de Bellvitge Barcelona
Spain Hosp. Univ. Vall D Hebron Barcelona
Spain Complejo Hospitalario de Jaen Jaen
Spain Hosp. Univ. 12 de Octubre Madrid
Spain Hosp. Univ. La Paz Madrid
Spain Corporacio Sanitari Parc Tauli Sabadell
Spain Hosp. Clinico Univ. de Valencia Valencia
Spain Hosp. Univ. I Politecni La Fe Valencia
Turkey Adana City Hospital Adana
Turkey Diskapi Yildirim Beyazid Training and Research Hospital Ankara
Turkey Yildirim Beyazit University Yenimahalle Training and Research Hospital Ankara
Turkey Antalya Training And Research Hospital Antalya
Turkey Bakirkoy Training and Research Hospital Istanbul
Turkey Sisli Etfal Research Training Hospital Istanbul
Turkey Izmir Tepecik Training and Research Hospital Izmir
Ukraine Ivano-Frankivsk Regional Clinical Hospital Ivano-Frankivsk
Ukraine Institute of Spine and JointPathology named after Prof.Sytenko of NationalAcademy of MedicalSciences Kharkiv
Ukraine Municipal Institution of Health Care 'Kharkiv Regional Clinical Traumatology Hospital' Kharkiv
Ukraine Kyiv Regional Clinical Hospital Kyiv
Ukraine Communal Institution of Lviv Regional Council 'Lypa Lviv Regional Hospital' Lviv-Vynnyky
Ukraine Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council Odesa
Ukraine Vinnytsya Regional Clinical Hospital named after M.I.Pirogov Vinnytsia
United States Central Research Associates, Inc. Birmingham Alabama
United States Denver Metro Orthopedics, PC Englewood Colorado
United States Memorial Hermann Memorial City Medical Center Houston Texas
United States Bowen Hefley Orthopedics Little Rock Arkansas
United States Arizona Research Center Phoenix Arizona
United States DMI Research Pinellas Park Florida
United States Gulfcoast Research Institute Sarasota Florida
United States University Orthopedic and Joint Replacement Center Tamarac Florida
United States Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California

Sponsors (2)

Lead Sponsor Collaborator
Janssen Research & Development, LLC Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Bulgaria,  Canada,  Greece,  Hungary,  Israel,  Italy,  Japan,  Poland,  Portugal,  Russian Federation,  South Africa,  Spain,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated) Total VTE was defined as the composite of clinical events committee (CEC)-adjudicated proximal and/or distal Deep Vein Thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death. Up to Day 14
Secondary Number of Participants With Any Bleeding Event (CEC-adjudicated) Any bleeding was defined as the composite of major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) criteria modified for the surgical setting, clinically relevant nonmajor bleeding events, or minimal bleeding events as assessed by the CEC. Up to Day 14; Up to Day 52
Secondary Number of Participants With Total VTE (CEC-adjudicated) Total VTE was defined as the composite of (CEC-adjudicated) proximal and/or DVT (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal PE, or any death. Up to Day 52
Secondary Number of Participants With Composite of Major and Clinically Relevant Nonmajor Bleeding (CRNM) Events (CEC-adjudicated) Composite of Major bleeding event (BE): Fatal bleeding; bleeding that is symptomatic and occurs in critical area/organ and/or; extrasurgical site bleeding causing fall in Hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; surgical site bleeding that requires second intervention open, arthroscopic, endovascular,or hemarthrosis resulting in prolonged hospitalization, deep wound infection and/or either unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: Epistaxis, Gastrointestinal bleed,Hematuria,Bruising/ecchymosis,Hemoptysis,Hematoma. Up to Day 14, Up to Day 52
Secondary Number of Participants With Major Bleeding Events (CEC-adjudicated) Number of participants with major BE (adjudicated by CEC) were reported. Major Bleeding events were defined as: fatal bleeding; bleeding that is symptomatic and occurs in critical area/organ and/or; extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; either unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. Up to Day 14; Up to Day 52
Secondary Number of Participants With CRNM Bleeding Events (CEC-adjudicated) Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma. Up to Day 14; Up to Day 52
Secondary Number of Participants With Minimal Bleeding Events (CEC-adjudicated) Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma. Up to Day 14; Up to Day 52
Secondary Number of Participants With Major or CRNM Bleeding Events (CEC-adjudicated) Major Bleeding events were defined as: fatal bleeding; bleeding that is symptomatic and occurs in critical area/organ and/or; extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; either unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma. Up to Day 14; Up to Day 52
Secondary Number of Participants With Major VTE (CEC-adjudicated) Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. Up to Day 52
Secondary Number of Participants With Major VTE (CEC-adjudicated) Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. Up to Day 14
Secondary Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated) Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. Up to Day 14
Secondary Number of Participants With Proximal DVT (CEC-adjudicated) Number of participants with proximal DVT (CEC-adjudicated) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. Up to Day 52
Secondary Number of Participants With Distal DVT (CEC-adjudicated) Number of participants with distal DVT (CEC-adjudicated) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. Up to Day 14
Secondary Number of Participants With Distal DVT (CEC-adjudicated) Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. Up to Day 52
Secondary Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated) Number of participants with nonfatal PE (adjudicated by CEC) were reported. Up to Day 14
Secondary Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated) Number of participants with nonfatal PE (adjudicated by CEC) were reported. Up to Day 52
Secondary Number of Participants With Deaths (CEC-adjudicated) Number of participants with deaths (CEC-adjudicated) were reported. Up to Day 14
Secondary Number of Participants With Deaths (CEC-adjudicated) Number of participants with deaths (CEC-adjudicated) were reported. Up to Day 52
Secondary Apparent Clearance (CL/F) of JNJ-70033093 Apparent clearance of a drug was defined as a measure of the rate at which a drug got metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Up to Day 14
Secondary Apparent Volume of Distribution (V/F) of JNJ-70033093 V/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Up to Day 14
Secondary Impact of Selected Demographics: Apparent Clearance (CL/F) Based on Sex Impact of demographic character (sex) on CL/F was assessed. Up to Day 14
Secondary Impact of Selected Demographic: Age on CL/F Impact of age on CL/F was assessed. Up to Day 14
Secondary Impact of Selected Demographic: Weight on CL/F Impact of weight on CL/F was assessed. Up to Day 14
Secondary Impact of Selected Laboratory Values: Renal Function on CL/F Impact of renal function on CL/F was assessed. The outcome measure was reported based on CRCL. Up to Day 14
Secondary Impact of Selected Demographics: Sex on Apparent Volume of Distribution (V/F) Impact of sex on V/F was assessed. Up to Day 14
Secondary Impact of Selected Demographics : Age on V/F Impact of age on V/F was assessed. Up to Day 14
Secondary Impact of Selected Demographics : Weight on V/F Impact of weight on V/F was assessed. Up to Day 14
Secondary Impact of Selected Laboratory Values: Renal Function on V/F Impact of renal function on V/F was assessed. The outcome measure is reported based on CRCL. Up to Day 14
Secondary Trend Test for Primary Efficacy Event Rate (CEC Adjudicated) by Multiple Comparison Procedure - Modelling (MCP-Mod) Approach The dose-response trend test based on the MCP-Mod framework consisted of contrast tests defined by prespecified candidate models (4 Emax dose-response models with varying degrees of ED50). Each model was evaluated for significance of trend, based on its optimal contrast, resulting in four t-test statistics, one for each candidate model. The t-test statistics were adjusted for the fact that 4 candidate models were included in the trend testing. The dose response of the drug was then established if the maximum of the t-test statistics exceeded the 95th percentile critical value. Here 'number' signifies the estimated response rate. Up to 14 days
Secondary Trend Test for the Composite of On-Treatment Major and Clinically Relevant Nonmajor Bleeding (CEC Adjudicated) by MCP-Mod Approach The dose-response trend test based on the MCP-Mod framework consisted of contrast tests defined by prespecified candidate models (4 Emax dose-response models with varying degrees of ED50). Each model was evaluated for significance of trend, based on its optimal contrast, resulting in four t-test statistics, one for each candidate model. The t-test statistics were adjusted for the fact that 4 candidate models were included in the trend testing. The dose response of the drug was then established if the maximum of the t-test statistics exceeded the 95th percentile critical value. Here 'number' signifies the estimated response rate. Up to 14 days
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