Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008961

Trial Description

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Title

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

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Trial Acronym

EINSTEIN Jr

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

[---]*

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Organizational Data

  •   DRKS00008961
  •   2015/09/03
  •   2014/09/05
  •   no
  •   [---]*
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Secondary IDs

  •   2014-000565-47 
  •   NCT02234843  (ClinicalTrials.gov)
  •   14372  (Bayer)
  •   2014-000565-47 
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Health Condition or Problem studied

  •   Venous Thromboembolism
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Interventions/Observational Groups

  •   Drug: Rivaroxaban (Xarelto, BAY59-7939)
  •   Drug: Rivaroxaban (Xarelto, BAY59-7939)
  •   Drug: Standard of Care
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Composite number of all symptomatic recurrent venous thromboembolism; time frame: Up to 3 months
- Composite number of overt major and clinically relevant non-major bleeding; time frame: Up to 3 months

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Secondary Outcome

- Composite number of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging.; time frame: Up to 3 months

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Belgium
  •   Brazil
  •   Canada
  •   France
  •   Germany
  •   Hong Kong
  •   Ireland
  •   Israel
  •   Italy
  •   Japan
  •   Mexico
  •   Netherlands
  •   Poland
  •   Russian Federation
  •   Spain
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2014/11/30
  •   160
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   6   Months
  •   17   Years
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Additional Inclusion Criteria

- Children aged 6 months 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

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Exclusion Criteria

- Active bleeding or high risk for bleeding contraindicating anticoagulant therapy

- An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2

- 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 x 10^9/L

- 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), i.e. 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, i.e. rifampicin, rifabutin,
phenobarbital, phenytoin and carbamazepine

- Childbearing potential without proper contraceptive measures, pregnancy or breast
feeding

- Hypersensitivity or any other contraindication listed in the local labeling for the
comparator treatment or experimental treatment

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Addresses

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    • Bayer
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    •   [---]*
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    • Janssen Research & Development, LLC
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    •   [---]*
    •   [---]*
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    • Bayer
    • Bayer Study Director 
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    •   [---]*
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    • Bayer Clinical Trials Contact 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2015/07/21
* This entry means the parameter is not applicable or has not been set.