Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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25 November 2019 |
Main ID: |
EUCTR2014-000565-47-SE |
Date of registration:
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18/04/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Rivaroxaban for treatment in venous thrombosis in children
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Scientific title:
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Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism - EINSTEIN Junior Phase III: oral rivaroxaban in young children with venous thrombosis |
Date of first enrolment:
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07/06/2016 |
Target sample size:
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170 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000565-47 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Brazil
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Bulgaria
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Canada
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China
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Finland
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France
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Germany
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Hong Kong
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Hungary
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Ireland
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Israel
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Italy
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Japan
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Mexico
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Netherlands
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Poland
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Portugal
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Romania
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Russian Federation
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Singapore
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Slovakia
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Spain
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Sweden
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Switzerland
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Bayer Clinical Trials Contact
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Address:
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13342
Berlin
Germany |
Telephone:
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+4930300139003 |
Email:
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clinical-trials-contact@bayer.com |
Affiliation:
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Bayer AG |
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Name:
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Bayer Clinical Trials Contact
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Address:
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13342
Berlin
Germany |
Telephone:
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+4930300139003 |
Email:
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clinical-trials-contact@bayer.com |
Affiliation:
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Bayer AG |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Children aged 6 months to < 18 years with confirmed venous thromboembolism who receive initial treatment with therapeutic dosages of UFH, LMWH or fondaparinux and require anticoagulant therapy for at least 90 days.
2. Informed consent provided and, if applicable, child assent provided
3. For children younger than 6 months:
- Gestational age at birth of at least 37 weeks.
- Oral feeding / nasogastric / gastric feeding for at least 10 days
- Body weight = 2600 g Are the trial subjects under 18? yes Number of subjects for this age range: 170 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. Active bleeding or bleeding risk contraindicating anticoagulant therapy
2. An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (in children younger than 1 year, serum creatinine results above 97.5th percentile excludes participation)
3. Hepatic disease which is associated either: with coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) > 5x upper level of normal (ULN) or total bilirubin (TB) > 2x ULN with direct bilirubin > 20% of the total
4. Platelet count < 50 x 109/L
5. Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure > 95th age percentile
6. Life expectancy < 3 months
7. Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), including but not limited to all human immunodeficiency virus protease Inhibitors and the follwoing azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed). For exceptions, see Section 4.4 of the Study Protocol.
8. Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine.
9. Childbearing potential without proper contraceptive measures, pregnancy or breast feeding.
10. Hypersensitivity or any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
11. Inability to cooperate with the study procedures
12. Previous assignment to treatment during this study
13. Participation in a study with an investigational drug or medical device within 30 days prior to randomization
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Venous Thrombosis MedDRA version: 20.0
Level: LLT
Classification code 10066899
Term: Venous thromboembolism
System Organ Class: 100000004866
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Intervention(s)
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Product Name: Xarelto Product Code: BAY59-7939 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-8 Current Sponsor code: BAY 59-7939 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5-
Product Name: Xarelto Product Code: BAY59-7939 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-8 Current Sponsor code: BAY 59-7939 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5-
Trade Name: Xarelto 10 mg Product Name: Xarelto Product Code: BAY59-7939 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-8 Current Sponsor code: BAY 59-7939 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-
Trade Name: Xarelto 15 mg Product Name: Xarelto Product Code: BAY59-7939 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-8 Current Sponsor code: BAY 59-7939 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15-
Trade Name: Xarelto 20 mg Product Name: Xarelto Product Code: BAY59-7939 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-8 Current Sponsor code: BAY 59-7939 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20-
Product Name: fondaparinux Pharmaceutical Form: Solution for injection INN or Proposed INN: FONDAPARINUX SODIUM CAS Number: 114870-03-0 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 0.1-
Product Name: vitamin K antagonist Pharmaceutical Form: Tablet INN or Proposed INN: WARFARIN CAS Number: 81-81-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: depend on patient-
Product Name: low molecular weight heparin Pharmaceutical Form: Solution for injection INN or Proposed INN: Enoxaparin CAS Number:
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Primary Outcome(s)
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Main Objective: The primary efficacy objective is: To assess the incidence of symptomatic recurrent venous thromboembolism
The principal safety objective is: ? To assess the incidence of overt major and clinically relevant non-major bleeding.
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Secondary Objective: The secondary efficacy objective is: To assess the incidence of symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging. An additional objective is: To characterize the pharmacokinetic / pharmacodynamics profile of rivaroxaban.
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Primary end point(s): 1. Efficacy: The composite of all symptomatic recurrent venous thromboembolism
2. Safety: The composite of overt major and clinically relevant non-major bleeding.
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Timepoint(s) of evaluation of this end point: 1. At the end of the main study treatment period: After 90 days of treatment and again at 30 days post treatment (For children below 2 years + catheter related thrombosis: After 30 days of treatment and again at 30 days post treatment)
2. At the end of main study treatment period: After 90 days of treatment and again at 30 days post treatment (For children below 2 years + catheter related thrombosis: After 30 days of treatment and again at 30 days post treatment)
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1. At the end of the main study treatment period:
After 90 days of treatment and again at 30 days post treatment
(For children below 2 years + catheter related thrombosis: After 30 days of treatment and again at 30 days post treatment)
2. PK and PD as defined in the protocol
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Secondary end point(s): 1. The composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging.
2. Results of pharmacokinetics (PK)/ pharmacodynamics (PD) analyses
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Secondary ID(s)
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2014-000565-47-ES
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BAY59-7939/14372
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Source(s) of Monetary Support
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Bayer AG
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Ethics review
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Status: Approved
Approval date:
Contact:
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