Oral Rivaroxaban in Children With Venous Thrombosis (EINSTEINJunior)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bayer
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01684423
First received: September 11, 2012
Last updated: October 2, 2014
Last verified: October 2014
  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.


Condition Intervention Phase
Venous Thrombosis
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Other: Standard of care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 30-day, Open-label, Active-controlled, Randomized Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children With Various Manifestations of Venous Thrombosis

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Composite number of major and clinically relevant non major bleeding events after 31 days [ Time Frame: After 31 days ] [ Designated as safety issue: Yes ]
  • Composite number of major and clinically relevant non major bleeding events after 60 days [ Time Frame: After 60 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Composite number of all recurrent venous thromboembolisms and asymptomatic deterioration after 31 days [ Time Frame: After 31 days ] [ Designated as safety issue: Yes ]
  • Composite number of all recurrent venous thromboembolisms after 60 days [ Time Frame: After 60 days ] [ Designated as safety issue: Yes ]
  • Prothrombin time [ Time Frame: 3x at day 15 (at 0h, 3h, 7h) and 1x at day 31 (at 22h) ] [ Designated as safety issue: No ]
  • Activated partial thromboplastin time [ Time Frame: 3x at day 15 (at 0h, 3h, 7h) and 1x at day 31 (at 22h) ] [ Designated as safety issue: No ]
  • Anti-factor Xa activity [ Time Frame: 3x at day 15 (at 0h, 3h, 7h) and 1x at day 31 (at 22h) ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban
Rivaroxaban will be provided according to an age- and body weight-adjusted dosing schedule to achieve a similar exposure in children as that observed in adults treated for VTE (venous thromboembolism) with 20 mg rivaroxaban daily. Rivaroxaban will be provided as a tablet for children 12 to 18 years. Once the age-and body weight-adjusted dosing regimen has been finally confirmed for the age group 6 to < 12 years, rivaroxaban will be provided as tablets (and subsequently as oral suspension) for this age group.
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Active Comparator: Standard of care
Children randomized to the comparator group will continue with the anticoagulant treatment that was used prior to study randomization.
Other: Standard of care

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 6 to < 18 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 and who will enter their last month of intended anticoagulant treatment
  • Hemoglobin, platelets, creatinine and alanine aminotransferase (ALT) and total bilirubin evaluated within 10 days prior to randomization
  • 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 < 100 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684423

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 56 Study Locations
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01684423     History of Changes
Other Study ID Numbers: 14373, 2011-004539-30
Study First Received: September 11, 2012
Last Updated: October 2, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Ethikkommission
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: German Institute of Medical Documentation and Information
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Switzerland: Swissmedic
United States: Food and Drug Administration

Additional relevant MeSH terms:
Venous Thromboembolism
Venous Thrombosis
Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thromboembolism
Vascular Diseases
Rivaroxaban
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014