Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008960

Trial Description

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Title

30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children With Various Manifestations of Venous Thrombosis

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Trial Acronym

EINSTEINJunior

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The purpose of this study is to find out whether rivaroxaban is safe to use in children and
how long it stays in the body. There will also be a check for bleeding and worsening of
blood clots.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00008960
  •   2015/09/02
  •   2012/09/11
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2011-004539-30 
  •   NCT01684423  (ClinicalTrials.gov)
  •   14373  (Bayer)
  •   2011-004539-30 
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Health Condition or Problem studied

  •   Venous Thrombosis
  •   I80 -  Phlebitis and thrombophlebitis
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Interventions/Observational Groups

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

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   [---]*
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Primary Outcome

- Composite number of major and clinically relevant non major bleeding events after 31 days; time frame: After 31 days
- Composite number of major and clinically relevant non major bleeding events after 60 days; time frame: After 60 days

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Secondary Outcome

- Composite number of all recurrent venous thromboembolisms and asymptomatic deterioration after 31 days; time frame: After 31 days
- Composite number of all recurrent venous thromboembolisms after 60 days; time frame: After 60 days
- Prothrombin time; time frame: 3x at day 15 (at 0h, 3h, 7h) and 1x at day 31 (at 15 h for oral suspension and 22 h for tablet)
- Activated partial thromboplastin time; time frame: 3x at day 15 (at 0h, 3h, 7h) and 1x at day 31 (at 15 h for oral suspension and 22 h for tablet)
- Anti-factor Xa activity; time frame: 3x at day 15 (at 0h, 3h, 7h) and 1x at day 31 (at 15 h for oral suspension and 22 h for tablet)

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Canada
  •   France
  •   Germany
  •   Israel
  •   Italy
  •   Netherlands
  •   Switzerland
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2013/02/27
  •   50
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Children aged 6 to < 18 years who have been treated for at least 2 months or, in case
of catheter-related thrombosis, for at least 6 weeks with LMWH (low molecular weight
heparin), fondaparinux and/or VKA (vitamin K antagonist) for documented symptomatic
or asymptomatic venous thrombosis - Hemoglobin, platelets, creatinine and alanine
aminotransferase (ALT) and total bilirubin evaluated within 10 days prior to
randomization

- Informed consent provided and, if applicable, child assent provided

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Exclusion Criteria

- Active bleeding or high risk for bleeding contraindicating anticoagulant therapy

- Symptomatic progression of venous thrombosis during preceding anticoagulant treatment

- Planned invasive procedures, including lumbar puncture and removal of non
peripherally placed central lines during study treatment

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

- Hepatic disease which is associated with 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 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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Bayer
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    • Janssen Research & Development, LLC
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    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • 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 .
  •   3
  •   2015/07/21
* This entry means the parameter is not applicable or has not been set.