Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children
NCT ID: NCT02497716
Last Updated: 2019-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
47 participants
INTERVENTIONAL
2015-11-04
2018-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Rivaroxaban
Single arm, open label study
Rivaroxaban (Xarelto, BAY59-7939
Single dose of reconstituted rivaroxaban granules
Interventions
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Rivaroxaban (Xarelto, BAY59-7939
Single dose of reconstituted rivaroxaban granules
Eligibility Criteria
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Inclusion Criteria
* Gestational age at birth of at least 37 weeks
* Oral feeding/ nasogastric/ gastric feeding for at least 10 days
* Normal PT and aPTT within 10 days prior to planned study drug administration
* Written informed consent provided and, if applicable, child assent provided
Exclusion Criteria
* Planned invasive procedures, including removal of central lines, within 24 hours before and after single dose intake
* An estimate glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
* 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 \> 2x ULN with direct bilirubin \> 20% of the total.
* Platelet count \< 50 x 10\^9/L
* Hypertension (defined as systolic and/or diastolic blood pressure \>95th percentile for age)
* Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, e.g., all human immunodeficiency virus protease inhibitors and the following azoleantimycotic agents: ketoconazole, itraconazole, voriconazole, and posaconazole, if used systemically (fluconazole is allowed)
* Concomitant use of strong inducers of CYP3A4, e.g., rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
* Inability to cooperate with the study procedures
* Hypersensitivity to rivaroxaban
* Participation in a study with an investigational drug other than rivaroxaban or a medical device within 30 days prior to treatment
* History of gastrointestinal disease or surgery associated with impaired absorption
2 Months
12 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital Oakland
Oakland, California, United States
Riley Hospital For Children
Indianapolis, Indiana, United States
Carolinas Healthcare System
Charlotte, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
UZ Leuven Gasthuisberg
Leuven, , Belgium
University of Alberta Hospital
Edmonton, Alberta, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
HUS Lastenklinikka
HUS, , Finland
Turun yliopistollinen keskussairaala, kantasairaala
Turku, , Finland
Hôpital Arnaud de Villeneuve - Montpellier
Montpellier, , France
Hopital Necker les enfants malades - Paris
Paris, , France
University of Semmelweis/ Semmelweis Egyetem
Budapest, , Hungary
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
A.O.U. Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
A.O. di Padova
Padua, Veneto, Italy
Hospital de Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain
Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Countries
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Related Links
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Click here to find results for studies related to Bayer Healthcare products.
Other Identifiers
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2015-000962-76
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17992
Identifier Type: -
Identifier Source: org_study_id
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