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

Phase 1

Completed

• Conditions: Thrombosis
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939

• Registration Number: NCT02497716
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-12
• Study First Submitted QC: 2015-07-12
• Study First Posted: 2015-07-14
• Study Start: 2015-11-04
• Primary Completion: 2018-05-22
• Study Completion: 2018-05-22
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-14
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban (Xarelto, BAY59-7939	Single arm, open label study

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (21)

Children's Hospital Oakland; 🇺🇸 Oakland, California, United States

Riley Hospital For Children; 🇺🇸 Indianapolis, Indiana, United States

Carolinas Healthcare System; 🇺🇸 Charlotte, North Carolina, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

HUS Lastenklinikka; 🇫🇮 HUS, Finland

Hopital Necker les enfants malades - Paris; 🇫🇷 Paris, France

Hôpital Arnaud de Villeneuve - Montpellier; 🇫🇷 Montpellier, France

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Lombardia, Italy

A.O.U. Città della Salute e della Scienza di Torino; 🇮🇹 Torino, Piemonte, Italy

Ciutat Sanitària i Universitaria de la Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

UZ Leuven Gasthuisberg; 🇧🇪 Leuven, Belgium

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

University of Semmelweis/ Semmelweis Egyetem; 🇭🇺 Budapest, Hungary

A.O. di Padova; 🇮🇹 Padova, Veneto, Italy

Hospital de Sant Joan de Déu; 🇪🇸 Esplugues de LLobregat, Barcelona, Spain

Turun yliopistollinen keskussairaala, kantasairaala; 🇫🇮 Turku, Finland

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada