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Venous ThrombosisPhase 2EINSTEINJuniorNCT01684423

Oral Rivaroxaban in Children With Venous Thrombosis

A Phase 2 study testing Rivaroxaban (Xarelto, BAY59-7939), Active comparator and Rivaroxaban (BAY59-7939) suspension in people with Venous Thrombosis, run by Bayer at 59 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Venous Thrombosis
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939), Active comparator and Rivaroxaban (BAY59-7939) suspension
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
59 sitesin 10 countries
Study dates
19 Feb 2013to 1 Sep 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

59 sites in 10 countries.

59 sites in 10 countries

United States13 sites

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Cleveland, Ohio, 44106-2602

  • Study site

    Columbus, Ohio, 43205-2696

  • Study site

    Detroit, Michigan, 48201-2196

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Little Rock, Arkansas, 72202-3500

  • Study site

    Los Angeles, California, 90027-6089

  • Study site

    Minneapolis, Minnesota, 55404

  • Study site

    New Hyde Park, New York, 11040

  • Study site

    Orange, California, 92868-3974

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Richmond, Virginia, 23298

Other trials in United States

France7 sites

  • Study site

    Bordeaux, 33076

  • Study site

    Montpellier, 34295

  • Study site

    Nantes, 44093

  • Study site

    Paris, 75015

  • Study site

    Paris, 75019

  • Study site

    Rennes, 35033

  • Study site

    Toulouse, 31059

Other trials in France

Germany6 sites

  • Study site

    Berlin, 13353

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Erlangen, Bavaria, 91054

  • Study site

    Frankfurt am Main, Hesse, 60590

  • Study site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Study site

    Lübeck, Schleswig-Holstein, 23538

Other trials in Germany

Italy6 sites

  • Study site

    Bari, Apulia, 70124

  • Study site

    Genoa, Liguria, 16147

  • Study site

    Milan, Lombardy, 20122

  • Study site

    Padova, Veneto, 35128

  • Study site

    Pavia, Lombardy, 27100

  • Study site

    Turin, Piedmont, 10126

Other trials in Italy

Canada5 sites

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Hamilton, Ontario, L8N 3Z5

  • Study site

    Ottawa, Ontario, K1H 8L1

  • Study site

    Québec, G1V 4G2

  • Study site

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Israel5 sites

  • Study site

    Beersheba, 8410101

  • Study site

    Haifa, 3109601

  • Study site

    Jerusalem, 9112001

  • Study site

    Petah Tikva, 4920235

  • Study site

    Ramat Gan, 5262000

Other trials in Israel

Netherlands5 sites

  • Study site

    Amsterdam, 1081 HV

  • Study site

    Amsterdam

  • Study site

    Nijmegen, 6525 GA

  • Study site

    Rotterdam, 3015 GJ

  • Study site

    Utrecht, 3584 CX

Other trials in Netherlands

Switzerland5 sites

  • Study site

    Basel, Canton of Basel-City, 4056

  • Study site

    Bern, 3010

  • Study site

    Lucerne, 6000

  • Study site

    Sankt Gallen, Canton of St. Gallen, 9006

  • Study site

    Zurich, 8032

Other trials in Switzerland

Austria4 sites

  • Study site

    Graz, Styria, 8036

  • Study site

    Innsbruck, Tyrol, 6020

  • Study site

    Linz, Upper Austria, 4020

  • Study site

    Vienna, 1090

Other trials in Austria

Australia3 sites

  • Study site

    Parkville, Victoria, 3052

  • Study site

    South Brisbane, 4101

  • Study site

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official 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

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.

Being tested
Rivaroxaban (Xarelto, BAY59-7939), Active comparator, Rivaroxaban (BAY59-7939) suspension
Medical subject headings
Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 comparatorDrug

    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) suspensionDrug

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

Study groups in NCT01684423
Study groupRoleWhat they receive
Rivaroxaban (BAY59-7939) tablet, OD, Age: 12 - <18ExperimentalSubjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR (immediate-release) tablet once daily (OD) under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Comparator, Age: 12 - <18 yearsActive comparatorSubjects aged from 12 - <18 years 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).
Receives: Drug: Active comparator
Rivaroxaban (BAY59-7939) tablet, OD, Age: 6 - <12 yearsExperimentalSubjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kg received a dose (equivalent to 20 mg in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban (BAY59-7939) suspension, BID, Age: 6 - <12 yearsExperimentalSubjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily (BID). Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
Receives: Drug: Rivaroxaban (BAY59-7939) suspension
Comparator, Age: 6 - <12 yearsActive comparatorSubjects aged from 6 - <12 years 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 INR-adjusted (vitamin K antagonist).
Receives: Drug: Active comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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).

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

Secondary outcomes (6)

  1. Number of Subjects With Symptomatic Recurrent Venous Thromboembolism

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

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

  2. Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden

    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.

    Measured: Repeat imaging at the end of the 30 day treatment period

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

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

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

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

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

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

  5. Anti-factor Xa Values at Specified Time Points

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2012 (estimated)
  2. Study start19 Feb 2013
  3. Primary completion1 Sep 2016
  4. Study completion1 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01684423
Sponsor's protocol ID
14373
Other IDs
2011-004539-30
Acronym
EINSTEINJunior
Status last verified
Aug 2017
First submitted
11 Sep 2012
Last updated
21 Sep 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rivaroxaban (Xarelto, BAY59-7939), Active comparator and Rivaroxaban (BAY59-7939) suspension in people with Venous Thrombosis, run by Bayer at 59 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, France, Germany, Italy, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01684423.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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