Trial Condition(s):
Phase I study on rivaroxaban granules for oral suspension formulation in children
17992
Not Available
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