Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Nov 2015

Typical duration for phase_1

Geographic Reach

8 countries

21 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

July 12, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed

4 months until next milestone

Study Start

First participant enrolled

November 4, 2015

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2018

Completed

Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

July 12, 2015

Last Update Submit

April 14, 2019

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (2)

AUC (area under the curve)
Only PK will be tested in central lab
4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration
Cmax (maximum observed drug concentration)
Only PK will be tested in central lab
4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration

Secondary Outcomes (3)

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

Study Arms (1)

Rivaroxaban

EXPERIMENTAL

Single arm, open label study

Drug: Rivaroxaban (Xarelto, BAY59-7939

Interventions

Rivaroxaban (Xarelto, BAY59-7939DRUG

Single dose of reconstituted rivaroxaban granules

Rivaroxaban

Eligibility Criteria

Age2 Months - 12 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Bayerlead
Janssen Research & Development, LLCcollaborator

Study Sites (21)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Children's Hospital Oakland

Oakland, California, 94609, United States

Location

Riley Hospital For Children

Indianapolis, Indiana, 46202, United States

Location

Carolinas Healthcare System

Charlotte, North Carolina, 28204, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205-2696, United States

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

HUS Lastenklinikka

HUS, 00029, Finland

Location

Turun yliopistollinen keskussairaala, kantasairaala

Turku, 20520, Finland

Location

Hôpital Arnaud de Villeneuve - Montpellier

Montpellier, 34059, France

Location

Hopital Necker les enfants malades - Paris

Paris, 75015, France

Location

University of Semmelweis/ Semmelweis Egyetem

Budapest, 1094, Hungary

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

Location

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

Turin, Piedmont, 10126, Italy

Location

A.O. di Padova

Padua, Veneto, 35128, Italy

Location

Hospital de Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

Bayer Study Director
Bayer
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 12, 2015

First Posted

July 14, 2015

Study Start

November 4, 2015

Primary Completion

May 22, 2018

Study Completion

May 22, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

CA(4)BE(1)IT(3)FR(2)HU(1)US(5)ES(3)FI(2)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

Rivaroxaban

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (21)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

Rivaroxaban

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (21)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations