check_circleStudy Completed

Venous Thromboembolism

Bayer Identifier:

14374

ClinicalTrials.gov Identifier:

NCT02309411

EudraCT Number:

2014-000566-22

EU CT Number:

Not Available
EINSTEIN Junior Phase II: oral rivaroxaban in young children with venous thrombosis

Trial purpose

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. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.

Key Participants Requirements

Sex

Both

Age

6 - 5 Years
  • - Children aged 6 months to < 6 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, alanine aminotransferase (ALT) and bilirubin evaluated within 10 days prior to randomization
    - Informed consent provided

  • - 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 m^2
    - 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 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
    - Hypersensitivity or any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
    - Inability to cooperate with the study procedures
    - Previous randomization to this study
    - Participation in a study with an investigational drug or medical device within 30 days prior to randomization

Trial summary

Enrollment Goal
46
Trial Dates
January 2015 - April 2017
Phase
Phase 2
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Wien, 1090, Austria
Withdrawn
Innsbruck, 6020, Austria
Withdrawn
Graz, 8036, Austria
Withdrawn
Linz, 4020, Austria
Completed
Chicago, 60611, United States
Withdrawn
Los Angeles, 90095, United States
Withdrawn
Miami, 33155, United States
Completed
Children's Healthcare of AtlantaAtlanta, 30322, United States
Withdrawn
Philadelphia, 19104-4399, United States
Completed
Gainesville, 32610, United States
Completed
Indianapolis, 46202, United States
Withdrawn
Los Angeles, 90027-6089, United States
Withdrawn
Lansing, 48912, United States
Completed
Bern, 3010, Switzerland
Withdrawn
Luzern, 6000, Switzerland
Completed
Parkville, 3052, Australia
Completed
St. Petersburg, 197022, Russia
Withdrawn
Kirov, 610027, Russia
Withdrawn
Sankt-Peterburg, 197110, Russia
Withdrawn
Moscow, 119049, Russia
Completed
Nizhny Novgorod, 603136, Russia
Withdrawn
Krasnodar, 350013, Russia
Withdrawn
Yekaterinburg, 620149, Russia
Withdrawn
Kansas City, 64108-9898, United States
Withdrawn
Jacksonville, 32207, United States
Withdrawn
Fort Worth, 76104, United States
Withdrawn
São Paulo, Brazil
Withdrawn
Lübeck, 23538, Germany
Withdrawn
Berlin, 13353, Germany
Withdrawn
Halle, 06120, Germany
Completed
Newcastle Upon Tyne, NE1 4LP, United Kingdom
Withdrawn
Glasgow, G51 4TF, United Kingdom
Withdrawn
Esplugues de LLobregat, 08950, Spain
Withdrawn
AMSTERDAM, 1105 AZ, Netherlands
Withdrawn
UTRECHT, 3584 CX, Netherlands
Completed
NIJMEGEN, 6525 GA, Netherlands
Withdrawn
AMSTERDAM, 1081 HV, Netherlands
Withdrawn
ROTTERDAM, 3015 CE, Netherlands
Withdrawn
Belo Horizonte, 30130-100, Brazil
Completed
São Paulo, Brazil
Withdrawn
Campinas, 130839 970, Brazil
Completed
São Paulo, 01227-200, Brazil
Completed
Birmingham, B4 6NH, United Kingdom
Withdrawn
Manchester, M13 9WL, United Kingdom
Completed
Milano, 20122, Italy
Completed
Torino, 10126, Italy
Completed
Cardiff, CF14 4XW, United Kingdom
Completed
Valencia, 46026, Spain
Completed
Barcelona, 08035, Spain
Withdrawn
A Coruña, 15006, Spain
Withdrawn
Madrid, 28046, Spain
Withdrawn
Sevilla, 41013, Spain
Withdrawn
MONTPELLIER, 34059, France
Withdrawn
PARIS, 75015, France
Withdrawn
BORDEAUX, 33000, France
Withdrawn
TOULOUSE Cedex 9, 31059, France
Withdrawn
Frankfurt, 60590, Germany
Completed
Pensacola, 32504, United States
Terminated
Olsztyn, 10-561, Poland
Withdrawn
Lodz, 91-738, Poland
Withdrawn
BRUXELLES - BRUSSEL, 1200, Belgium
Withdrawn
EDEGEM, 2650, Belgium
Completed
Ramat Gan, 5262000, Israel
Completed
Jerusalem, 9112001, Israel
Withdrawn
Petach Tikva, 4920235, Israel
Completed
Padova, 35128, Italy
Withdrawn
Cork, Ireland
Withdrawn
Freiburg, 79106, Germany
Withdrawn
Hamilton, L8N 3Z5, Canada
Completed
Toronto, M5G 1X8, Canada
Completed
Setagaya, 157-8535, Japan
Withdrawn
Fuchu, 183-8561, Japan
Withdrawn
Moscow, 117997, Russia
Completed
Moscow, 117997, Russia
Withdrawn
Ottawa, K1H 8L1, Canada
Withdrawn
Afula, 1834111, Israel
Withdrawn
Las Vegas, 89109, United States
Withdrawn
Pavia, 27100, Italy
Withdrawn
Bahia Blanca, B8001HXM, Argentina
Withdrawn
Buenos Aires, C1425EFD, Argentina
Withdrawn
LEUVEN, 3000, Belgium
Withdrawn
Madrid, 28007, Spain
Withdrawn
Budapest, 1094, Hungary
Completed
Budapest, 1097, Hungary
Withdrawn
HUS, 00029, Finland
Withdrawn
Turku, 20520, Finland
Terminated
Gdansk, 80-952, Poland
Withdrawn
LILLE, 59037, France

Primary Outcome

  • Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events
    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, for example (e.g.) intracranial, intraspinal, intraocular, pericardial, intraarticular, 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).
    date_rangeTime Frame:
    During or within 2 days after stop of study treatment (up to 32 days)
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Number of Subjects With Symptomatic Recurrent Venous Thromboembolism
    Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence, which is the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE of venous thrombosis, had to be documented using appropriate (repeat) imaging test.
    date_rangeTime Frame:
    From start of the study treatment up to 30-days post study treatment period (approximately 60 days)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging
    The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. At the end of the 30-day treatment period, a repeat imaging of the thrombus was performed. The images of the index event and repeat imaging were adjudicated by the central independent adjudication committee (CIAC). The thrombotic burden at the time of the index event was compared to the thrombotic burden at the time of repeat imaging. The outcome of the adjudication was classified as normalized, improved, no relevant change, deteriorated, or not evaluable. Due to missing repeated imaging, thrombotic burden assessments were not done in some subjects.
    date_rangeTime Frame:
    At the end of the 30-day treatment period
    enhanced_encryption
    Safety Issue:
    No
  • 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. Day 30 (10-16 hours post-dose) was considered as a baseline.
    date_rangeTime Frame:
    Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)
    enhanced_encryption
    Safety Issue:
    No
  • 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. Day 30 (10-16 hours post-dose) was considered as a baseline.
    date_rangeTime Frame:
    Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)
    enhanced_encryption
    Safety Issue:
    No
  • Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points
    Concentration of rivaroxaban in plasma was measured at Day 1, 15 and 30 at specified time points. In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Day 1 (30-90 minutes, 2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose)
    enhanced_encryption
    Safety Issue:
    No

Trial design

30-day, single-arm study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in young children with various manifestations of venous thrombosis
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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