Trial Condition(s):

Thromboembolism

Rivaroxaban for treatment in venous or arterial thrombosis in neonates (Einstein Jr)

Bayer Identifier:

17618

ClinicalTrials.gov Identifier:

NCT02564718

EudraCT Number:

2014-002385-74

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
10
Trial Dates
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Phase
1/2
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28007

Status
Completed
 
Locations

Investigative Site

Ramat Gan, Israel, 5262000

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20122

Status
Completed
 
Locations

Investigative Site

MONTPELLIER, France, 34059

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Izmir, Turkey, 35-100

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28046

Status
Completed
 
Locations

Investigative Site

Erlangen, Germany, 91052

Status
Completed
 

Trial Design