Trial Condition(s):
Phase I study on rivaroxaban granules for oral suspension formulation in children
To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability
- 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
Locations | Status | ||
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Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Hospital de Sant Joan de Déu Esplugues de LLobregat, Spain, 08950 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Hospital General Universitario Gregorio Marañón Madrid, Spain, 28007 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations A.O.U. Città della Salute e della Scienza di Torino Torino, Italy, 10126 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations A.O. di Padova Padova, Italy, 35128 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Hopital Necker les enfants malades - Paris PARIS, France, 75015 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Turun yliopistollinen keskussairaala, kantasairaala Turku, Finland, 20520 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations HUS Lastenklinikka HUS, Finland, 00029 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Riley Hospital For Children Indianapolis, United States, 46202 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Carolinas Healthcare System Charlotte, United States, 28204 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations University of Semmelweis/ Semmelweis Egyetem Budapest, Hungary, 1094 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Children's Hospital Oakland Oakland, United States, 94609 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Hospital for Sick Children Toronto, Canada, M5G 1X8 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations McMaster Children's Hospital Hamilton, Canada, L8N 3Z5 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Children's Hospital of Eastern Ontario Ottawa, Canada, K1H 8L1 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Arkansas Children's Hospital Little Rock, United States, 72202 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations University of Alberta Hospital Edmonton, Canada, T6G 2B7 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Nationwide Children's Hospital Columbus, United States, 43205-2696 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Hôpital Arnaud de Villeneuve - Montpellier MONTPELLIER, France, 34059 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Single-dose study testing rivaroxaban granules for oral suspension formulation in children from 2 months to 12 years with previous thrombosis
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1