Phase 2 Completed N=10 Other

Rivaroxaban for Treatment in Venous or Arterial Thrombosis in Neonates

Source: ClinicalTrials.gov NCT02564718 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Jul 2018

Primary outcomePrimary: Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1 — 85.2001; 42.6837; 73.7641; 12.1027 microgram per liter (mcg/L)

Summary

The purpose of this study is to find out whether rivaroxaban is safe and effective to use in children age newborn to less than 6 months and how long it stays in the body and how it is used in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.

Outcome Measures

Outcome	Result	p-value
PRIMARY Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1	85.2001; 42.6837; 73.7641; 12.1027	—
PRIMARY Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3	32.2879; 102.3285; 9.1716	—
PRIMARY Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 8	2.5696; NA	—
PRIMARY Change From Baseline in Prothrombin Time at Day 1	11.6; 0.025	—
PRIMARY Change From Baseline in Prothrombin Time at Day 3	3.74; 1.13	—
PRIMARY Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 1	13.6; 2.33	—
PRIMARY Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 3	7.02; 3.47	—
PRIMARY Anti-factor Xa Activity (Anti-Xa) Values at Day 1	63.3; 18.0	—
PRIMARY Anti-factor Xa Activity (Anti-Xa) Values at Day 3	67.3; 59.8	—
PRIMARY Anti-factor Xa Activity (Anti-Xa) Values at Day 8	7.25; 9.92	—
SECONDARY Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events	0; 0; 0; 0	—
SECONDARY Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging	0; 0; 0; 0	—

Eligibility Criteria

Inclusion Criteria

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.
Gestational age at birth of at least 37 weeks.
Hemoglobin, platelets, creatinine, ALT and total and direct bilirubin assessed within 10 days prior to enrollment.
Oral feeding/nasogastric/gastric feeding for at least 10 days.
Informed consent provided.
Body weight >2600 g

Exclusion Criteria

Active bleeding or high risk for bleeding contraindicating anticoagulant therapy, including history of intra-ventricular bleeding.
Symptomatic progression of thrombosis during preceding anticoagulant treatment.
Planned invasive procedures, including lumbar puncture and removal of non-peripherally placed central lines during study treatment.
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.
Creatinine >1.5 times of normal.
Uncontrolled Hypertension defined as >95th percentile.
History of gastrointestinal disease or surgery associated with impaired absorption.
Platelet count <100 x 109/L.
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)
Concomitant use of strong inducers of CYP3A4, e.g. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
Indication for anticoagulant therapy other than current thrombosis.
Indication for antiplatelet therapy or non-steroid anti-inflammatory drug (NSAID) therapy. Incidental use is allowed.
Hypersensitivity to rivaroxaban or its excipients.
Participation in a study with an investigational drug or medical device within 30 days prior to enrollment.

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Data sourced from ClinicalTrials.gov (NCT02564718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.