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

Phase 1

• Conditions: Venous or arterial thrombosis; MedDRA version: 19.1Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-03
• Last Update Posted: 18 June 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 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.Indication for 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

Primary Outcome Measures

Name	Time	Method
Main Objective: •to characterize the pharmacokinetic/pharmacodynamic profile of a 7-day treatment with oral rivaroxaban;Secondary Objective: •to assess the incidence of major bleeding and clinically relevant non-major bleeding<br>•to assess the incidence of symptomatic recurrent thromboembolism and <br>•to assess asymptomatic deterioration in the thrombotic burden on repeat imaging<br>;Primary end point(s): PK/PD modeling, using population approaches will be used to describe the pharmacokinetics of rivaroxaban, and to relate anticoagulant parameters of rivaroxaban with plasma concentrations.;Timepoint(s) of evaluation of this end point: After last patient. last visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. The occurrence of recurrent venous or arterial thromboembolism and asymptomatic deterioration in thrombotic burden will be summarized.<br>2. All safety analyses will be performed on the safety population. Bleeding events observed later will be described separately. Individual listings of major and clinically relevant non-major bleeding will be provided. <br>3. The occurrence of recurrent venous or arterial thromboembolism and asymptomatic deterioration in thrombotic burden ;Timepoint(s) of evaluation of this end point: 1. After last patient,ast visit<br>2.The analysis will primarily focus on bleeding that occurred during or within 2 days after stop of rivaroxaban<br>3. After last patient, last visit