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.
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
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
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
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
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
Israel5 sites
Study site
Beersheba, 8410101
Study site
Haifa, 3109601
Study site
Jerusalem, 9112001
Study site
Petah Tikva, 4920235
Study site
Ramat Gan, 5262000
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
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
Austria4 sites
Study site
Graz, Styria, 8036
Study site
Innsbruck, Tyrol, 6020
Study site
Linz, Upper Austria, 4020
Study site
Vienna, 1090
Australia3 sites
Study site
Parkville, Victoria, 3052
Study site
South Brisbane, 4101
Study site
Westmead, New South Wales, 2145
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.
- Conditions
- Venous Thrombosis
- 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 group | Role | What they receive |
|---|---|---|
| Rivaroxaban (BAY59-7939) tablet, OD, Age: 12 - <18 | Experimental | Subjects 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 years | Active comparator | Subjects 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 years | Experimental | Subjects 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 years | Experimental | Subjects 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 years | Active comparator | Subjects 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.
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)
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
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
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
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
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
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.
- First posted13 Sep 2012 (estimated)
- Study start19 Feb 2013
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01684423
- Acronym / sponsor ID
- EINSTEINJunior / 14373
- Conditions
- Venous Thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 19 Feb 2013 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 13 Sep 2012 (estimated)
- Results
- Posted 21 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban (BAY59-7939) tablet, OD, Age: 12 - <18 | Experimental | Drug: Rivaroxaban (Xarelto, BAY59-7939)Subjects 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. |
| Comparator, Age: 12 - <18 years | Active comparator | Drug: Active 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). |
| Rivaroxaban (BAY59-7939) tablet, OD, Age: 6 - <12 years | Experimental | Drug: Rivaroxaban (Xarelto, BAY59-7939)Subjects 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. |
| Rivaroxaban (BAY59-7939) suspension, BID, Age: 6 - <12 years | Experimental | Drug: Rivaroxaban (BAY59-7939) suspensionSubjects 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. |
| Comparator, Age: 6 - <12 years | Active comparator | Drug: Active 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). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939)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. | Drug | Rivaroxaban (BAY59-7939) tablet, OD, Age: 12 - <18, Rivaroxaban (BAY59-7939) tablet, OD, Age: 6 - <12 years |
| Active comparatorSubjects 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). | Drug | Comparator, Age: 12 - <18 years, Comparator, Age: 6 - <12 years |
| Rivaroxaban (BAY59-7939) suspensionSubjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. | Drug | Rivaroxaban (BAY59-7939) suspension, BID, Age: 6 - <12 years |
Primary outcome
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).
6 secondary outcomes
Number of Subjects With Symptomatic Recurrent Venous Thromboembolism
Time frame: From start of study drug administration until end of the 30-day treatment period
Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden
Time frame: Repeat imaging at the end of the 30 day treatment period
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
59 sites in 10 countries: see every site and its status.
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?
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.