Clinical trial NCT01684423: Oral Rivaroxaban in Children With Venous Thrombosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thrombosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2012-09-13
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

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 \< 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

Primary outcomes:
measure: Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events
timeFrame: From start of study drug administration until end of the 30-day treatment period
Secondary outcomes:
measure: Number of Subjects With Symptomatic Recurrent Venous Thromboembolism
timeFrame: From start of study drug administration until end of the 30-day treatment period
measure: Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden
timeFrame: Repeat imaging at the end of the 30 day treatment period
measure: Change From Baseline in Prothrombin Time at Specified Time Points
timeFrame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31
measure: Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points
timeFrame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31
measure: Anti-factor Xa Values at Specified Time Points
timeFrame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31
measure: Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points
timeFrame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: New Hyde Park
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Westmead
country: Australia
state: New South Wales
city: Parkville
country: Australia
state: Victoria
city: South Brisbane
country: Australia
city: Linz
country: Austria
state: Oberösterreich
city: Graz
country: Austria
state: Steiermark
city: Innsbruck
country: Austria
state: Tirol
city: Wien
country: Austria
city: Edmonton
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Quebec
country: Canada
city: BORDEAUX cedex
country: France
city: Montpellier Cedex
country: France
city: NANTES Cedex 1
country: France
city: Paris
country: France
city: Paris
country: France
city: Rennes Cedex
country: France
city: TOULOUSE Cedex 9
country: France
city: Freiburg
country: Germany
state: Baden-Württemberg
city: Erlangen
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Dresden
country: Germany
state: Sachsen
city: Lübeck
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Genova
country: Italy
state: Liguria
city: Milano
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Torino
country: Italy
state: Piemonte
city: Bari
country: Italy
state: Puglia
city: Padova
country: Italy
state: Veneto
city: Amsterdam
country: Netherlands
city: Amsterdam
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Utrecht
country: Netherlands
city: Basel
country: Switzerland
state: Basel-Stadt
city: St. Gallen
country: Switzerland
state: Sankt Gallen
city: Bern
country: Switzerland
city: Luzern
country: Switzerland
city: Zürich
country: Switzerland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: