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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22 May 2017 |
Main ID: |
EUCTR2014-000566-22-AT |
Date of registration:
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23/06/2014 |
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 young children
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Scientific title:
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30-day, single-arm study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in young children with various manifestations of venous thrombosis - EINSTEIN Junior Phase II-part B: oral rivaroxaban in young children with venous |
Date of first enrolment:
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25/07/2014 |
Target sample size:
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20 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000566-22 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
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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Canada
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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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Netherlands
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Poland
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Russian Federation
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Spain
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Switzerland
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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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CTP Team/Ref:"EU CTR"/ Bayer Pharma AG
13342
Berlin
Germany |
Telephone:
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Email:
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clinical-trials-contact@bayerhealthcare.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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CTP Team/Ref:"EU CTR"/ Bayer Pharma AG
13342
Berlin
Germany |
Telephone:
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Email:
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clinical-trials-contact@bayerhealthcare.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 < 6 years who have been treated for at least 2 months or, in case of catheter
related thrombosis, for at least 6 weeks with LMWH, fondaparinux and/or VKA for documented symptomatic or asymptomatic venous thrombosis
2. Hemoglobin, platelets, creatinine, alanine aminotransferase (ALT) and bilirubin evaluated within 10 days prior to Visit 2
3. Informed consent provided Are the trial subjects under 18? yes Number of subjects for this age range: 20 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 high risk for bleeding contraindicating anticoagulant therapy
2. Symptomatic progression of venous thrombosis during preceding anticoagulant treatment
3. Planned invasive procedures, including lumbar puncture and removal of non-peripherally placed central lines during study treatment
4. An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
5. Hepatic disease which is associated with either: 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
6. Platelet count < 50 x 109/L
7. Hypertension defined as > 95th age percentile a
8. Life expectancy < 3 months
9. 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 (fluconazole is allowed)
10. Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
11. Hypersensitivity or any other contraindication listed in the local labeling for the experimental treatment
12. Inability to cooperate with the study procedures
13. Previous enrollment to this study
14. Participation in a study with an investigational drug or medical device within 30 days prior to Visit 2.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Venous Thrombosis MedDRA version: 19.0
Level: LLT
Classification code 10066899
Term: Venous thromboembolism
System Organ Class: 100000004866
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Intervention(s)
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Product Name: Xarelto Product Code: BAY59-7939 Pharmaceutical Form: Oral suspension INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-8 Current Sponsor code: BAY 59-7939 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.1%-
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Primary Outcome(s)
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Primary end point(s): Composite of major and clinically relevant non-major bleeding
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Secondary Objective: 1) to assess the incidence of recurrent venous thromboembolism 2) to assess asymptomatic deterioration in the thrombotic burden on repeat imaging 3) to characterize the pharmacokinetic/pharmacodynamic profile of a 30-day treatment with oral rivaroxaban.
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Main Objective: to assess the incidence of major bleeding and clinically relevant non-major bleeding
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Timepoint(s) of evaluation of this end point: During or within 2 days after stop of study treatment
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1. At 31 Days
2. Day1 (post dose at.5-1.5h, 2.5-4h),day 15 (post dose at 2-8h) and day 30 (post dose at 10-16)
3. Day1 (post dose at.5-1.5h, 2.5-4h),day 15 (post dose at 2-8h) and day 30 (post dose at 10-16)
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Secondary end point(s): 1. Composite of all recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging; results of pharmacokinetics (PK) / pharmacodynamics (PD).
2. Prothrombin time
3. Activated partial thromboplastin time
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Secondary ID(s)
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BAY59-7939/14374
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2014-000566-22-IE
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Source(s) of Monetary Support
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Bayer AG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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