check_circleStudy Completed

Venous Thromboembolism

Bayer Identifier:

14372

ClinicalTrials.gov Identifier:

NCT02234843

EudraCT Number:

2014-000565-47

EU CT Number:

Not Available
EINSTEIN Junior: oral rivaroxaban in children with venous thrombosis

Trial purpose

The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.

Key Participants Requirements

Sex

All

Age

0 - 17 Years
  • - Children aged birth to < 18 years with confirmed venous thromboembolism who receive initial treatment with therapeutic dosages of UFH (unfractionated heparin), LMWH (low molecular weight heparin) or fondaparinux and require anticoagulant therapy for at least 90 days. However, children aged birth to < 2 years with catheter-related thrombosis require anticoagulant therapy for at least 30 days.
    - For children younger than 6 months:
     -- Gestational age at birth of at least 37 weeks.
     -- Oral feeding/nasogastric/gastric feeding for at least 10 days.
     -- Body weight ≥2600 g

  • - Active bleeding or bleeding risk contraindicating anticoagulant therapy
    - An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m*2 (in children younger than 1 year, serum creatinine results above 97.5th percentile excludes participation)
    - Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or ALT> 5x upper level of normal (ULN) or total bilirubin > 2x ULN with direct bilirubin > 20% of the total
    - Platelet count < 50 x 109/L
    - Sustained uncontrolled hypertension defined as > 95th age percentile
    - Life expectancy < 3 months
    - Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), including but not limited to all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
    - Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
    - Childbearing potential without proper contraceptive measures, pregnancy or breast feeding

Trial summary

Enrollment Goal
500
Trial Dates
November 2014 - January 2019
Phase
Phase 3
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Little Rock, 72202-3500, United States
Withdrawn
New Hyde Park, 11040, United States
Completed
Los Angeles, 90095, United States
Completed
Chicago, 60611, United States
Completed
Columbus, 43205-2696, United States
Completed
Philadelphia, 19104, United States
Completed
Los Angeles, 90027-6089, United States
Completed
Houston, 77030, United States
Completed
Bern, 3010, Switzerland
Completed
Luzern, 6000, Switzerland
Completed
St. Petersburg, 197022, Russian Federation
Withdrawn
Kirov, 610027, Russian Federation
Completed
St. Petersburg, 197110, Russian Federation
Completed
Moscow, 119049, Russian Federation
Completed
Nizhny Novgorod, 603136, Russian Federation
Completed
Krasnodar, 350013, Russian Federation
Completed
Yekaterinburg, 620028, Russian Federation
Withdrawn
Moscow, 117997, Russian Federation
Completed
Volgograd, 400138, Russian Federation
Completed
Moscow, 117997, Russian Federation
Completed
Guadalajara, Mexico
Terminated
Durham, 27710, United States
Completed
Gainesville, 32610, United States
Completed
Kansas City, 64108-9898, United States
Completed
Indianapolis, 46202, United States
Completed
Fort Worth, 76104, United States
Withdrawn
Orange, 92868, United States
Completed
Cleveland, 44106, United States
Completed
St. Petersburg, 33701, United States
Completed
Atlanta, 30322, United States
Completed
Miami, 33155, United States
Completed
Lansing, 48912, United States
Completed
Newcastle Upon Tyne, NE1 4LP, United Kingdom
Completed
Glasgow, G51 4TF, United Kingdom
Completed
AMSTERDAM, 1105 AZ, Netherlands
Completed
UTRECHT, 3584 CX, Netherlands
Completed
GRONINGEN, 9713 GZ, Netherlands
Withdrawn
AMSTERDAM, 1081 HV, Netherlands
Completed
ROTTERDAM, 3015 CE, Netherlands
Completed
Sao Paulo, 04023-061, Brazil
Withdrawn
Belo Horizonte, 30130100, Brazil
Withdrawn
São Paulo, Brazil
Completed
Campinas, 13083-970, Brazil
Completed
São Paulo, 01227-200, Brazil
Completed
Birmingham, B4 6NH, United Kingdom
Completed
Manchester, M13 9WL, United Kingdom
Completed
Cardiff, CF14 4XW, United Kingdom
Completed
Sheffield, S10 2TH, United Kingdom
Completed
Esplugues de LLobregat, 08950, Spain
Withdrawn
Valencia, 46026, Spain
Completed
Barcelona, 08023, Spain
Completed
A Coruña, 15006, Spain
Withdrawn
Madrid, 28046, Spain
Withdrawn
Sevilla, 41013, Spain
Completed
Padova, 35128, Italy
Completed
Milano, 20122, Italy
Completed
Torino, 10126, Italy
Completed
Parkville, 3052, Australia
Completed
MONTPELLIER, 34059, France
Completed
PARIS, 75015, France
Withdrawn
BORDEAUX, 33000, France
Completed
TOULOUSE Cedex 9, 31059, France
Withdrawn
Lübeck, 23538, Germany
Completed
Dresden, 01307, Germany
Completed
Berlin, 13353, Germany
Withdrawn
Frankfurt, 60590, Germany
Completed
Halle, 06120, Germany
Completed
Erlangen, 91054, Germany
Completed
Wien, 1090, Austria
Completed
Innsbruck, 6020, Austria
Completed
Graz, 8036, Austria
Completed
Linz, 4020, Austria
Withdrawn
Olsztyn, 10-561, Poland
Withdrawn
Lodz, 91-738, Poland
Completed
Cincinnati, 45229-3039, United States
Completed
Phoenix, 85016, United States
Completed
San Diego, 92123, United States
Completed
Jacksonville, 32207, United States
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
EDEGEM, 2650, Belgium
Completed
Ramat Gan, 5262000, Israel
Completed
Jerusalem, 9112001, Israel
Completed
Petach Tikva, 4920235, Israel
Withdrawn
Haifa, 3109601, Israel
Completed
Crumlin, 12, Ireland
Withdrawn
Cork, Ireland
Withdrawn
Freiburg, 79106, Germany
Completed
Hamilton, L8N 3Z5, Canada
Completed
Toronto, M5G 1X8, Canada
Withdrawn
Pachuca, 42070, Mexico
Withdrawn
Setagaya, 157-8535, Japan
Withdrawn
Fuchu, 183-8561, Japan
Completed
NIJMEGEN, 6525 GA, Netherlands
Withdrawn
Shinjuku-ku, 162-8666, Japan
Completed
Afula, 1834111, Israel
Completed
Ottawa, K1H 8L1, Canada
Completed
Calgary, T3B 6A8, Canada
Withdrawn
Queretaro, 78000, Mexico
Withdrawn
Pavia, 27100, Italy
Withdrawn
Bahia Blanca, B8001HXM, Argentina
Withdrawn
Buenos Aires, C1425EFD, Argentina
Completed
LEUVEN, 3000, Belgium
Withdrawn
Budapest, 1094, Hungary
Completed
Budapest, 1097, Hungary
Withdrawn
Shatin, Hong Kong
Withdrawn
Oakland, 94609, United States
Completed
Dallas, 75235, United States
Completed
Hong Kong, Hong Kong
Withdrawn
Baltimore, 21287, United States
Withdrawn
HUS, 00029, Finland
Completed
Turku, 20520, Finland
Withdrawn
Gdansk, 80-952, Poland
Completed
Leeds, LS1 3EX, United Kingdom
Withdrawn
LILLE, 59037, France
Completed
Montreal, H4A 3J1, Canada
Completed
Sao Paulo, 05403-000, Brazil
Completed
Beijing, 100045, China
Withdrawn
Beijing, 100730, China
Completed
Beijing, 100034, China
Withdrawn
Shanghai, 201102, China
Withdrawn
Shanghai, 200092, China
Withdrawn
Chongqing, 400014, China
Completed
Shanghai, China
Withdrawn
Beijing, 100037, China
Completed
Hangzhou, 310056, China
Completed
Pensacola, 32504, United States
Withdrawn
Shanghai, 200127, China
Withdrawn
Genova, 16147, Italy
Completed
Solna, 171 64, Sweden
Withdrawn
Malmö, 205 02, Sweden
Completed
Ciudad de México, 06720, Mexico
Completed
South Brisbane, 4101, Australia
Completed
Obu, 474-8710, Japan
Completed
Bunkyo-ku, 113-8655, Japan
Withdrawn
Sagamihara, 252-0375, Japan
Completed
Azumino, 399-8288, Japan
Withdrawn
Ufa, 450106, Russian Federation
Completed
Edinburgh, EH9 1LF, United Kingdom
Completed
Kemerovo, 650002, Russian Federation
Withdrawn
Haifa, 3109601, Israel
Completed
Kazan, 420138, Russian Federation
Completed
San Miguel de Tucumán, 4000, Argentina
Withdrawn
Sofia, 1309, Bulgaria
Withdrawn
Ankara, 06100, Turkey
Withdrawn
Izmir, 35100, Turkey
Completed
Konya, 42080, Turkey
Withdrawn
Antalya, 07059, Turkey
Withdrawn
Bursa, 16059, Turkey
Withdrawn
Izmir, 35340, Turkey
Completed
Istanbul, 34093, Turkey
Withdrawn
Ankara, 06500, Turkey
Withdrawn
Kocaeli, 41380, Turkey
Completed
Adana, 01130, Turkey
Completed
Bratislava, 833 41, Slovakia
Completed
Edmonton, T6G 2B7, Canada
Completed
Oxford, OX3 9DU, United Kingdom
Withdrawn
Porto, 4200-319, Portugal
Completed
Carnaxide, 2795-53, Portugal
Withdrawn
Berlin, 13353, Germany
Completed
Singapore, 119228, Singapore
Completed
Singapore, 229 899, Singapore
Completed
Zürich, 8032, Switzerland
Withdrawn
Erlangen, 91052, Germany
Withdrawn
Akita, 010-8543, Japan
Withdrawn
St. Gallen, 9006, Switzerland
Withdrawn
Madrid, 28046, Spain
Withdrawn
Cluj-Napoca, 400177, Romania
Withdrawn
Targu Mures, 540136, Romania
Withdrawn
Timisoara, 300011, Romania
Withdrawn
Salta, A4400ESE, Argentina
Withdrawn
San MIguel de Tucumán, Argentina
Withdrawn
Fukuoka, 813-0017, Japan
Completed
London, SW3 6NP, United Kingdom
Withdrawn
RENNES CEDEX, 35056, France
Withdrawn
PESSAC cedex, 33604, France

Primary Outcome

  • Incidence rates of all symptomatic recurrent venous thromboembolism during the main treatment period
    The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population
    date_rangeTime Frame:
    During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)
  • Incidence rates of all symptomatic recurrent venous thromboembolism during extended treatment period
    Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference Population. 'NA' denotes data that cannot be calculated.
    date_rangeTime Frame:
    During extended treatment period: up to month 12.
  • Number of subjects with the composite of all symptomatic recurrent venous thromboembolism during the 30 days post-study treatment period (i.e. >2 and ≤ 30 days after stop of study medication)
    The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Age group with primary efficacy outcome was reported.
    date_rangeTime Frame:
    More than 2 and up to 30 days after stop of study medication
  • Incidence rates of the composite of treatment emergent overt major bleeding and clinically relevant non-major (CRNM) bleeding during main treatment period
    The Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteriafor major bleeding, but associated with: medical intervention, or unscheduled contact (visit or telephone call) with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life (such as loss of school days or hospitalization).
    date_rangeTime Frame:
    During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)
  • Incidence rates of the composite of treatment emergent overt major bleeding and clinically relevant non-major (CRNM) bleeding during extended treatment period
    Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. The CIAC classified bleeding as: Major bleeding defined as overt bleeding and: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteriafor major bleeding, but associated with: medical intervention, or unscheduled contact (visit or telephone call) with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life (such as loss of school days or hospitalization). 'NA' denotes data that cannot be calculated.
    date_rangeTime Frame:
    During extended treatment period: up to month 12.

Secondary Outcome

  • Incidence rates of the composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration in thrombotic burden on repeat imaging during the main treatment period
    The secondary efficacy outcome defined as the composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging as assessed by central independent adjudication committee. (CIAC) Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population
    date_rangeTime Frame:
    During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)
  • AUC(0-24)ss in plasma
    AUC(0-24)ss: Area under the concentration vs. time curve from time 0 to 24 hours at steady state.
    date_rangeTime Frame:
    over 24 hours
  • Cmax,ss in plasma
    Maximum drug concentration in measured matrix at steady state during a dosage interval
    date_rangeTime Frame:
    0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours (one dosing interval in steady state)
  • Ctrough,ss in plasma
    Ctrough,ss refers to the drug concentration at the end of the dosage interval at steady state
    date_rangeTime Frame:
    0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours(one sampling interval in steady state)
  • Prothrombin time (PT) ratios to baseline: Rivaroxaban administered once daily (suspension and tablet) in the age group 12-<18 years
    Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
  • Prothrombin time (PT) ratios to baseline: Rivaroxaban administered once daily (suspension and tablet) in the age group 6-<12 years
    Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
  • Prothrombin time (PT) ratios to baseline: Rivaroxaban administered twice daily (suspension and tablet) in the age group 6-<12 years
    Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
  • Prothrombin time (PT) ratios to baseline: Rivaroxaban administered twice daily (suspension) in the age group 2-<6 years
    Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
  • Prothrombin time (PT) ratios to baseline: Rivaroxaban administered twice daily (suspension) in the age group 0.5-<2 years
    Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
  • Prothrombin time (PT) ratios to baseline: Rivaroxaban administered three times daily (suspension) in the age group 2-<6 years
    Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
    date_rangeTime Frame:
    Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60
  • Prothrombin time (PT) ratios to baseline: Rivaroxaban administered three times daily (suspension) in the age group 0.5-<2 years
    Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
    date_rangeTime Frame:
    Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60
  • Prothrombin time (PT) ratios to baseline: Rivaroxaban administered three times daily (suspension) in the age group birth-<0.5 years
    Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
    date_rangeTime Frame:
    Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60
  • Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered once daily (suspension and tablet) in the age group 12-<18 years
    The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
  • Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered once daily (suspension and tablet) in the age group 6-<12 years
    The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
  • Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered twice daily (suspension and tablet) in the age group 6-<12 years
    The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
  • Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered twice daily (suspension) in the age group 2-<6 years
    The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
  • Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered twice daily (suspension) in the age group 0.5-<2 years
    The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
  • Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered three times daily (suspension) in the age group 2-<6 years
    The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
    date_rangeTime Frame:
    Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
  • Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered three times daily (suspension) in the age group 0.5-<2 years
    The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
    date_rangeTime Frame:
    Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
  • Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered three times daily (suspension) in the age group birth-<0.5 years
    The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
    date_rangeTime Frame:
    Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
  • Anti-Xa values: Rivaroxaban administered once daily (suspension and tablet) in the age group 12-<18 years
    This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90
  • Anti-Xa values: Rivaroxaban administered once daily (suspension and tablet) in the age group 6-<12 years
    This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90
  • Anti-Xa values: Rivaroxaban administered twice daily (suspension and tablet) in the age group 6-<12 years
    This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90
  • Anti-Xa values: Rivaroxaban administered twice daily (suspension) in the age group 2-<6 years
    This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90
  • Anti-Xa values: Rivaroxaban administered twice daily (suspension) in the age group 0.5-<2 years
    This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.
    date_rangeTime Frame:
    Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
  • Anti-Xa values: Rivaroxaban administered three times daily (suspension) in the age group 2-<6 years
    This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.
    date_rangeTime Frame:
    Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, and up to 16 hours on Day 90
  • Anti-Xa values: Rivaroxaban administered three times daily (suspension) in the age group 0.5-<2 years
    This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.
    date_rangeTime Frame:
    Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, and up to 16 hours on Day 90
  • Anti-Xa values: Rivaroxaban administered three times daily (suspension) in the age group birth-<0.5 years
    This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
    date_rangeTime Frame:
    Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60

Trial design

Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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