7-day study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties<br>of oral rivaroxaban in children from birth to less than 6 months with arterial or venous<br>thrombosis

Phase 2

Withdrawn

• Conditions: blood clot; thrombosis; 10064477

• Registration Number: NL-OMON44043
• Lead Sponsor: Bayer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 1

Inclusion Criteria

1. Children from birth to less than 6 months with documented symptomatic or asymptomatic venous or arterial thrombosis who have been treated with anticoagulant therapy for at least 5 days.
2. Gestational age at birth of at least 37 weeks.
3. Hemoglobin, platelets, creatinine, ALT and total and direct bilirubin assessed within
10 days prior to enrollment.
4. Oral feeding/nasogastric/gastric feeding for at least 10 days.
5. Informed consent provided.
6. Body weight >2600 g.

Exclusion Criteria

1. Active bleeding or high risk for bleeding contraindicating anticoagulant therapy, including history of intra-ventricular bleeding.
2. Symptomatic progression of thrombosis during preceding anticoagulant treatment.
3. Planned invasive procedures, including lumbar puncture and removal of nonperipherally placed central lines during study treatment.
4. Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) > 5x upper level of normal (ULN) or total bilirubin (TB) > 2x ULN with direct bilirubin > 20% of the total
5. Creatinine > 1.5 times of normal.
6. Uncontrolled hypertension defined as > 95th percentile.
7. History of gastrointestinal disease or surgery associated with impaired absorption.
8. Platelet count <100 x 109/L.
9. Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), e.g. all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed).
10. Concomitant use of strong inducers of CYP3A4, e.g. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine.
11. Indication for anticoagulant therapy other than current thrombosis.
12. An indication for continued antiplatelet therapy or non-steroid anti-inflammatory drug (NSAID) therapy. Incidental use is allowed.
13. Hypersensitivity to rivaroxaban or its excipients.
14. Participation in a study with an investigational drug or medical device within 30 days prior to enrollment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Results of pharmacokinetics (PK) / pharmacodynamics (PD) (prothrombin time,<br /><br>activated partial thromboplastin time and anti-factor Xa activity). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Composite of major and clinically relevant non-major bleeding. Composite of all<br /><br>symptomatic recurrent thromboembolism and asymptomatic deterioration in<br /><br>thrombotic burden on repeat imaging.</p><br>