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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23 July 2018 |
Main ID: |
EUCTR2015-000962-76-HU |
Date of registration:
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14/07/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Single-dose study testing a rivaroxaban dry powder to be diluted into an oral suspension in children from 6 months to 12 years with previous blood clot
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Scientific title:
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Single-dose study testing a rivaroxaban dry powder formulation for oral suspension in children from 6 months to 12 years with previous thrombosis - Phase 1 granules for oral suspension |
Date of first enrolment:
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09/09/2015 |
Target sample size:
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24 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000962-76 |
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
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Phase:
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Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Austria
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Belgium
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Canada
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Czech Republic
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Finland
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France
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Hungary
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Ireland
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Israel
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Italy
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Netherlands
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Spain
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Sweden
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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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CTP Team/Ref:"EU CTR"/ Bayer Pharma
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Address:
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13342
Berlin
Germany |
Telephone:
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Email:
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clinical-trials-contact@bayerhealthcare.com |
Affiliation:
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Bayer Health Care AG |
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Name:
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CTP Team/Ref:"EU CTR"/ Bayer Pharma
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Address:
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13342
Berlin
Germany |
Telephone:
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Email:
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clinical-trials-contact@bayerhealthcare.com |
Affiliation:
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Bayer Health Care AG |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.Children with an age between 6 months and <12 years who
have completed anticoagulant treatment at least 10 days prior
to the planned study drug administration
2. Normal prothrombin time (PT) and activated partial
thromboplastin time (aPTT) within 10 days prior to planned
study drug administration
3. Written informed consent provided and, if applicable, child
assent provided Are the trial subjects under 18? yes Number of subjects for this age range: 48 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. Planned invasive procedures, including removal of central
lines, within 24 hours before and after single dose intake
3. An estimate glomerular filtration rate (eGFR)
< 30 mL/min/1.73m2 calculated according to Cockcroft-Gault
formula
4. Hepatic disease which is associated either with: coagulopathy
leading to a clinically relevant bleeding risk, or alanine
aminotransferase (ALT) > 5x upper limit of normal (ULN), or
total bilirubin > 2x ULN with direct bilirubin > 20% of the
total
5. Platelet count < 50 x 109/L
6. Hypertension defined as systolic and/or diastolic blood
pressure >95th percentile for age)
7. Concomitant use of strong inhibitors of both CYP3A4 and
P-glycoprotein, e.g., all human immunodeficiency virus
protease inhibitors and the following azole-antimycotic
agents: ketoconazole, itraconazole, voriconazole, and
posaconazole, if used systemically (fluconazole is allowed)
8. Concomitant use of strong inducers of CYP3A4, e.g.,
rifampicin, rifabutin, phenobarbital, phenytoin and
carbamazepine
9. Inability to cooperate with the study procedures
10. Hypersensitivity to rivaroxaban
11. Participation in a study with an investigational drug other than
rivaroxaban or a medical device within 30 days prior to
treatment
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Thrombosis MedDRA version: 18.1
Level: PT
Classification code 10043607
Term: Thrombosis
System Organ Class: 10047065 - Vascular disorders
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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: Granules for oral suspension INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-8 Current Sponsor code: BAY59-7939 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1-
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Primary Outcome(s)
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Secondary Objective: • To document safety and tolerability in terms of AEs observed after administration of the rivaroxaban dry powder for suspension formulation
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Timepoint(s) of evaluation of this end point: Depending on age, PK samples are collected at several time points within 24 hours after drug administration
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Main Objective: • To characterize the pharmacokinetic profile of rivaroxaban administered as dry powder for suspension
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Primary end point(s): The primary variables for pharmacokinetics will be the standard pharmacokinetic (PK) parameters for exposure, area under the curve (AUC) and Cmax, derived via population PK approaches.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: At 24 hrs after drug administration with aftive followup for 7 (+3) days.
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Secondary end point(s): The principal safety outcome is the composite of major bleeding and clinically relevant non-major bleeding.
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Secondary ID(s)
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2015-000962-76-AT
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17992
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Source(s) of Monetary Support
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Bayer Health Care 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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