Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children

Completed · Phase 1

Conditions studied: Thrombosis

In brief

To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability

Key facts

Study ID

NCT02497716

Run by

Bayer

People needed

47

Starts

2015-11-04

Expected to finish

2018-05-22

Last updated by the study team

2019-04-16

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children with an age ≥2 months and weight between 3 and <12 kg, who have completed anticoagulant treatment at least 10 days prior to the planned study drug administration.
• 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

You may not qualify if…

• Active bleeding or high risk for bleeding, contraindicating anticoagulant therapy
• 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

Where it is running

• 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 — Padova, 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

Full record on ClinicalTrials.gov

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