Trial Condition(s):

Thrombosis

Phase I study on rivaroxaban granules for oral suspension formulation in children

Bayer Identifier:

17992

ClinicalTrials.gov Identifier:

NCT02497716

EudraCT Number:

2015-000962-76

Study Completed

Trial Purpose

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

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Summary

Enrollment Goal
47
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Hospital de Sant Joan de Déu

Esplugues de LLobregat, Spain, 08950

Status
Completed
 
Locations

Hospital General Universitario Gregorio Marañón

Madrid, Spain, 28007

Status
Completed
 
Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Completed
 
Locations

A.O.U. Città della Salute e della Scienza di Torino

Torino, Italy, 10126

Status
Completed
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Completed
 
Locations

Hopital Necker les enfants malades - Paris

PARIS, France, 75015

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Turun yliopistollinen keskussairaala, kantasairaala

Turku, Finland, 20520

Status
Completed
 
Locations

HUS Lastenklinikka

HUS, Finland, 00029

Status
Completed
 
Locations

Riley Hospital For Children

Indianapolis, United States, 46202

Status
Completed
 
Locations

Carolinas Healthcare System

Charlotte, United States, 28204

Status
Completed
 
Locations

University of Semmelweis/ Semmelweis Egyetem

Budapest, Hungary, 1094

Status
Completed
 
Locations

Children's Hospital Oakland

Oakland, United States, 94609

Status
Completed
 
Locations

Hospital for Sick Children

Toronto, Canada, M5G 1X8

Status
Completed
 
Locations

McMaster Children's Hospital

Hamilton, Canada, L8N 3Z5

Status
Completed
 
Locations

Children's Hospital of Eastern Ontario

Ottawa, Canada, K1H 8L1

Status
Completed
 
Locations

Arkansas Children's Hospital

Little Rock, United States, 72202

Status
Completed
 
Locations

University of Alberta Hospital

Edmonton, Canada, T6G 2B7

Status
Completed
 
Locations

Nationwide Children's Hospital

Columbus, United States, 43205-2696

Status
Completed
 
Locations

Hôpital Arnaud de Villeneuve - Montpellier

MONTPELLIER, France, 34059

Status
Completed
 

Trial Design