check_circleStudy Completed

Venous Thrombosis

Bayer Identifier:

14373

ClinicalTrials.gov Identifier:

NCT01684423

EudraCT Number:

2011-004539-30

EU CT Number:

Not Available
Oral Rivaroxaban in 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. There will also be a check for bleeding and worsening of blood clots.

Key Participants Requirements

Sex

Both

Age

6 - 17 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
64
Trial Dates
February 2013 - September 2016
Phase
Phase 2
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Lübeck, 23538, Germany
Completed
Dresden, 01307, Germany
Terminated
Frankfurt, 60590, Germany
Completed
Houston, 77030, United States
Completed
Columbus, 43205-2696, United States
Terminated
Philadelphia, 19104, United States
Completed
Los Angeles, 90027-6089, United States
Terminated
PARIS, 75019, France
Terminated
TOULOUSE Cedex 9, 31059, France
Completed
Genova, 16147, Italy
Completed
Torino, 10126, Italy
Completed
Bari, 70124, Italy
Completed
AMSTERDAM, Netherlands
Terminated
UTRECHT, 3584 CX, Netherlands
Completed
NIJMEGEN, 6525 GA, Netherlands
Completed
AMSTERDAM, 1081 HV, Netherlands
Terminated
ROTTERDAM, 3015 GJ, Netherlands
Terminated
Ramat Gan, 5262000, Israel
Completed
Jerusalem, 9112001, Israel
Completed
Petach Tikva, 4920235, Israel
Completed
Parkville, 3052, Australia
Completed
South Brisbane, 4101, Australia
Completed
Wien, 1090, Austria
Completed
Innsbruck, 6020, Austria
Completed
Graz, 8036, Austria
Completed
Zürich, 8032, Switzerland
Terminated
Basel, 4056, Switzerland
Completed
Bern, 3010, Switzerland
Terminated
St. Gallen, 9006, Switzerland
Terminated
Toronto, M5G 1X8, Canada
Terminated
Hamilton, L8N 3Z5, Canada
Terminated
Westmead, 2145, Australia
Completed
Ottawa, K1H 8L1, Canada
Completed
Milano, 20122, Italy
Completed
Berlin, 13353, Germany
Terminated
Richmond, 23298, United States
Terminated
Quebec, G1V 4G2, Canada
Terminated
Chicago, 60611, United States
Terminated
Cleveland, 44106-2602, United States
Completed
Indianapolis, 46202, United States
Terminated
Orange, 92868-3974, United States
Completed
PARIS, 75015, France
Completed
Montpellier Cedex, 34295, France
Terminated
BORDEAUX cedex, 33076, France
Terminated
Beer Sheva, 8410101, Israel
Completed
Minneapolis, 55404, United States
Terminated
Erlangen, 91054, Germany
Completed
Detroit, 48201-2196, United States
Terminated
Edmonton, T6G 2B7, Canada
Terminated
Little Rock, 72202-3500, United States
Completed
New Hyde Park, 11040, United States
Terminated
Linz, 4020, Austria
Terminated
Haifa, 3109601, Israel
Completed
Padova, 35128, Italy
Terminated
Freiburg, 79106, Germany
Terminated
Luzern, 6000, Switzerland
Terminated
RENNES CEDEX, 35033, France
Terminated
NANTES Cedex 1, 44093, France
Terminated
Pavia, 27100, Italy

Primary Outcome

  • 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).
    date_rangeTime Frame:
    From start of study drug administration until end of the 30-day treatment period

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime 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
    The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway.
    date_rangeTime 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
    The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.
    date_rangeTime 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
    Geometric and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
5

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find information about studies related to Bayer Healthcare products conducted in EuropeClick here to find results for studies related to Bayer Healthcare products.