Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children
- Registration Number
- NCT02497716
- Lead Sponsor
- Bayer
- Brief Summary
To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rivaroxaban Rivaroxaban (Xarelto, BAY59-7939 Single arm, open label study
- Primary Outcome Measures
Name Time Method AUC (area under the curve) 4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration Only PK will be tested in central lab
Cmax (maximum observed drug concentration) 4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration Only PK will be tested in central lab
- Secondary Outcome Measures
Name Time Method Prothrombin time (PT) Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration Activated partial thromboplastin time (aPTT) Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration Composite of major bleeding and clinically relevant non-major bleeding From dose administration until follow up call on day 8+3
Trial Locations
- Locations (21)
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
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
HUS Lastenklinikka
🇫🇮HUS, Finland
Hopital Necker les enfants malades - Paris
🇫🇷Paris, France
Hôpital Arnaud de Villeneuve - Montpellier
🇫🇷Montpellier, France
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Lombardia, Italy
A.O.U. Città della Salute e della Scienza di Torino
🇮🇹Torino, Piemonte, Italy
Ciutat Sanitària i Universitaria de la Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
University of Semmelweis/ Semmelweis Egyetem
🇭🇺Budapest, Hungary
A.O. di Padova
🇮🇹Padova, Veneto, Italy
Hospital de Sant Joan de Déu
🇪🇸Esplugues de LLobregat, Barcelona, Spain
Turun yliopistollinen keskussairaala, kantasairaala
🇫🇮Turku, Finland
McMaster Children's Hospital
🇨🇦Hamilton, Ontario, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada