Trial Condition(s):
Venous thrombosis
Oral Rivaroxaban in Children with Venous Thrombosis (EINSTEINJunior)
Bayer Identifier:
14373
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Lübeck, Germany, 23538 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 60590 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43205-2696 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19104 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90027-6089 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75019 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site TOULOUSE Cedex 9, France, 31059 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16147 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torino, Italy, 10126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bari, Italy, 70124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMSTERDAM, Netherlands | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site UTRECHT, Netherlands, 3584 CX | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIJMEGEN, Netherlands, 6525 GA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMSTERDAM, Netherlands, 1081 HV | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ROTTERDAM, Netherlands, 3015 GJ | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9112001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petach Tikva, Israel, 4920235 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Parkville, Australia, 3052 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site South Brisbane, Australia, 4101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zürich, Switzerland, 8032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Basel, Switzerland, 4056 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bern, Switzerland, 3010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Gallen, Switzerland, 9006 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5G 1X8 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamilton, Canada, L8N 3Z5 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Westmead, Australia, 2145 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ottawa, Canada, K1H 8L1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Richmond, United States, 23298 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quebec, Canada, G1V 4G2 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60611 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44106-2602 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Indianapolis, United States, 46202 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Orange, United States, 92868-3974 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75015 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montpellier Cedex, France, 34295 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BORDEAUX cedex, France, 33076 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beer Sheva, Israel, 8410101 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Minneapolis, United States, 55404 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Erlangen, Germany, 91054 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Detroit, United States, 48201-2196 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Edmonton, Canada, T6G 2B7 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Little Rock, United States, 72202-3500 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Hyde Park, United States, 11040 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4020 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3109601 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Padova, Italy, 35128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Freiburg, Germany, 79106 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Luzern, Switzerland, 6000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site RENNES CEDEX, France, 35033 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NANTES Cedex 1, France, 44093 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Number of Subjects With Major and Clinically Relevant Non-Major Bleeding EventsCentral 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).Timeframe: From start of study drug administration until end of the 30-day treatment period
Secondary Outcome
- Number of Subjects With Symptomatic Recurrent Venous ThromboembolismThe occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test.Timeframe: From start of study drug administration until end of the 30-day treatment period
- Number of Subjects With Asymptomatic Deterioration in Thrombotic BurdenThe 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.Timeframe: Repeat imaging at the end of the 30 day treatment period
- Change From Baseline in Prothrombin Time at Specified Time PointsProthrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.Timeframe: 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 PointsThe Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway.Timeframe: 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 PointsThe individual anti-Factor Xa activity was determined ex-vivo using a photometric method.Timeframe: 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 PointsGeometric and percentage geometric coefficient of variation (%CV) were reported.Timeframe: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31
Additional Information
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