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Completed

NCT Number: NCT01684423

Oral Rivaroxaban in Children With Venous Thrombosis

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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Key information

Conditions

Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Westmead, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 6 to < 18 years with documented symptomatic or asymptomatic venous thrombosis treated for at least 2 months or, in case of catheter related thrombosis, treated for at least 6 weeks with LMWH (low molecular weight heparin), , fondaparinux and/or VKA (vitamin K antagonist).
  • Informed consent provided and, if applicable, child assent provided

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.

Active Comparator

Drug

Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).

Rivaroxaban (BAY59-7939) suspension

Drug

Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily.

Primary outcomes

  1. Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events

    Time frame: From start of study drug administration until end of the 30-day treatment period

    Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and:

    • associated with a fall in hemoglobin of 2 gram/decilitre (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, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or
    • contributing to death.

    Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:

    • medical intervention, or
    • unscheduled contact (visit or telephone call) with a physician, or
    • cessation (temporary) 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).

Secondary outcomes

  1. Number of Subjects With Symptomatic Recurrent Venous Thromboembolism

    Time frame: From start of study drug administration until end of the 30-day treatment period

    The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test.

  2. Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden

    Time frame: Repeat imaging at the end of the 30 day treatment period

    The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. Asymptomatic deterioration in thrombotic burden was documented by the appropriate imaging test and the results were classified as normalized, improved, no relevant change, deteriorated, not evaluable or not available.

  3. Change From Baseline in Prothrombin Time at Specified Time Points

    Time frame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31

    Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.

  4. Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points

    Time frame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31

    The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway.

  5. Anti-factor Xa Values at Specified Time Points

    Time frame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31

    The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.

  6. Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points

    Time frame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31

    Geometric and percentage geometric coefficient of variation (%CV) were reported.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study 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

Acronym: EINSTEINJunior

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 13, 2012
Registry last updated
Sep 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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