Single-dose study testing a rivaroxaban dry powder to be diluted into an oral suspension in children from 6 months to 12 years with previous blood clot

Phase 1

• Conditions: Thrombosis; MedDRA version: 18.0Level: PTClassification code 10043607Term: ThrombosisSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-000962-76-ES
• Lead Sponsor: Bayer Health Care AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-10
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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
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: 24
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

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 calculated according to Cockcroft-Gault formula
4. Hepatic disease which is associated either with: coagulopathy
leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) > 5x upper limit 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

Study & Design

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