Single-dose study testing a rivaroxaban granules to be diluted into an oral suspension in children from 2 months to 12 years with previous blood clot

Phase 1

• Conditions: Thrombosis; MedDRA version: 20.0Level: PTClassification code 10043607Term: ThrombosisSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-000962-76-IT
• Lead Sponsor: BAYER AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-05-22
• Study Start: 2021-09-22
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

For group A and B
1.Children with an age between 6 months and <12 years who
have completed anticoagulant treatment at least 10 days prior
to the planned study drug administration.
For Group C:
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 29
For groups A, B and C:
2. Normal prothrombin time (PT) and activated partial
thromboplastin time (aPTT) within 10 days prior to planned
study drug administration
3. Written informed consent provided and, if applicable, child
assent provided
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

For groups A, B and C:
1.Active bleeding or high risk for bleeding, contraindicating
anticoagulant therapy
2. Planned invasive procedures, including removal of central
lines, within 24 hours before and after single dose intake
3. An estimate glomerular filtration rate (eGFR)
< 30 mL/min/1.73m2
4. Hepatic disease which is associated either with: coagulopathy
leading to a clinically relevant bleeding risk, or ALT > 5x upper level of normal (ULN), or
total bilirubin > 2x ULN with direct bilirubin > 20% of the
total
5. Platelet count < 50 x 109/L
6. Hypertension defined as systolic and/or diastolic blood
pressure >95th percentile for age)
7. Concomitant use of strong inhibitors of both CYP3A4 and
P-glycoprotein, e.g., all human immunodeficiency virus
protease inhibitors and the following azole-antimycotic
agents: ketoconazole, itraconazole, voriconazole, and
posaconazole, if used systemically (fluconazole is allowed)
8. Concomitant use of strong inducers of CYP3A4, e.g.,
rifampicin, rifabutin, phenobarbital, phenytoin and
carbamazepine
9. Inability to cooperate with the study procedures
10. Hypersensitivity to rivaroxaban
11. Participation in a study with an investigational drug other than
rivaroxaban or a medical device within 30 days prior to
treatment
For group C only:
12. history of gastrointestinal disease or surgery associated with impaired absorption

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: For Group A and B<br>Depending on age, PK samples are collected at several time points within<br>24 hours after drug administration<br>For Group C<br>PK samples are collected at several time points within 28 hours after<br>drug administration;Main Objective: ¿To characterize the pharmacokinetic profile of rivaroxaban administered as granules for oral suspension formulation ;Secondary Objective: ¿To document safety and tolerability in terms of AEs observed after administration of the rivaroxaban granules for oral suspension formulation;Primary end point(s): The primary variables for pharmacokinetics will be the standard<br>pharmacokinetic (PK) parameters for exposure, area under the curve<br>(AUC) and Cmax, derived via population PK approaches.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The principal safety outcome is the composite of major bleeding and<br>clinically relevant non-major bleeding.;Timepoint(s) of evaluation of this end point: At 24 hrs after drug administration with additional followup on day 8<br>(+3) days.