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

• Registration Number: EUCTR2015-000962-76-IE
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-09
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. For group A and B:
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 PT and 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: 58
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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 azoleantimycotic 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