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

Thrombosis Clinical Trial

Official title:

Single-dose Study Testing Rivaroxaban Granules for Oral Suspension Formulation in Children From 2 Months to 12 Years With Previous Thrombosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497716
• Other study ID #: 17992
• Secondary ID: 2015-000962-76
• Status: Completed
• Phase: Phase 1
• Start date: November 4, 2015
• Est. completion date: May 22, 2018

Study information

• Verified date: April 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 22, 2018
• Est. primary completion date: May 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939
Single dose of reconstituted rivaroxaban granules

Locations

Country	Name	City	State
Belgium	UZ Leuven Gasthuisberg	Leuven
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Hospital for Sick Children	Toronto	Ontario
Finland	HUS Lastenklinikka	HUS
Finland	Turun yliopistollinen keskussairaala, kantasairaala	Turku
France	Hôpital Arnaud de Villeneuve - Montpellier	Montpellier
France	Hopital Necker les enfants malades - Paris	Paris
Hungary	University of Semmelweis/ Semmelweis Egyetem	Budapest
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano	Lombardia
Italy	A.O. di Padova	Padova	Veneto
Italy	A.O.U. Città della Salute e della Scienza di Torino	Torino	Piemonte
Spain	Ciutat Sanitària i Universitaria de la Vall d'Hebron	Barcelona
Spain	Hospital de Sant Joan de Déu	Esplugues de LLobregat	Barcelona
Spain	Hospital General Universitario Gregorio Marañón	Madrid
United States	Carolinas Healthcare System	Charlotte	North Carolina
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Riley Hospital For Children	Indianapolis	Indiana
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Children's Hospital Oakland	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Finland,  France,  Hungary,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Prothrombin time (PT)		Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration
Secondary	Activated partial thromboplastin time (aPTT)		Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration
Secondary	Composite of major bleeding and clinically relevant non-major bleeding		From dose administration until follow up call on day 8+3

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