Rivaroxaban for treatment of venous or arterial blood clots in children from birth to less than 6 months

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Venous or arterial thrombosis

• Registration Number: EUCTR2014-002385-74-FI
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-27
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

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, alanine aminotransferase (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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 8
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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 non-peripherally 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 percentilea
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 clinical trial of medicinal product
• Study Design: Not specified