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

7-day study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in children from birth to less than 6 months with arterial or venous thrombosis - EINSTEIN Junior Phase l/ll in children from birth to less than 6 months.

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44043
Enrollment
1
Registered
2016-12-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood clot thrombosis

Interventions

Age- and body weight-adjusted three times daily dosing of rivaroxaban (oral suspension) during 7 days.
efficacy and safety
pediatric study
rivaroxaban
venous and arterial thrombosis

Sponsors

Bayer
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Results of pharmacokinetics (PK) / pharmacodynamics (PD) (prothrombin time, activated partial thromboplastin time and anti-factor Xa activity).—

Secondary

MeasureTime frame
Composite of major and clinically relevant non-major bleeding. Composite of all symptomatic recurrent thromboembolism and asymptomatic deterioration in thrombotic burden on repeat imaging.—

Countries

Australia, Austria, Canada, France, Germany, Israel, Italy, Poland, Spain, Switzerland, Turkey, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)