Rivaroxaban for treatment in venous thrombosis in young children

• Register: EUCTR
• Last refreshed on: 22 May 2017
• Main ID: EUCTR2014-000566-22-HU
• Date of registration: 28/07/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer HealthCare AG
• Public title: Rivaroxaban for treatment in venous thrombosis in young children
• Scientific title: 30-day, single-arm study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in young children with various manifestations of venous thrombosis - EINSTEIN Junior Phase II-part B: oral rivaroxaban in young children with venous
• Date of first enrolment: 09/09/2015
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000566-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Poland, Russian Federation, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer HealthCare AG

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer HealthCare AG

Key inclusion & exclusion criteria

Inclusion criteria:
1. Children aged 6 months to < 6 years who have been treated for at least 2 months or, in case of catheter
related thrombosis, for at least 6 weeks with LMWH, fondaparinux and/or VKA for documented symptomatic or asymptomatic venous thrombosis
2. Hemoglobin, platelets, creatinine, alanine aminotransferase (ALT) and bilirubin evaluated within 10 days prior to Visit 2
3. Informed consent provided
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
2. Symptomatic progression of venous thrombosis during preceding anticoagulant treatment
3. Planned invasive procedures, including lumbar puncture and removal of non-peripherally placed central lines during study treatment
4. An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
5. Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or ALT > 5x upper level of normal (ULN) or total bilirubin > 2x ULN with direct bilirubin > 20% of the total
6. Platelet count < 50 x 109/L
7. Hypertension defined as > 95th age percentile
8. Life expectancy < 3 months
9. Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e. 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, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
11. Hypersensitivity or any other contraindication listed in the local labeling for the experimental treatment
12. Inability to cooperate with the study procedures
13. Previous enrollment to this study
14. Participation in a study with an investigational drug or medical device within 30 days prior to Visit 2.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Venous Thrombosis
MedDRA version: 18.0 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 100000004866

Intervention(s)

Product Name: Xarelto
Product Code: BAY59-7939
Pharmaceutical Form: Oral suspension
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02-8
Current Sponsor code: BAY 59-7939
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.1-

Primary Outcome(s)

Primary end point(s): Composite of major and clinically relevant non-major bleeding

Secondary Objective: 1) to assess the incidence of recurrent venous thromboembolism
2) to assess asymptomatic deterioration in the thrombotic burden on repeat imaging
3) to characterize the pharmacokinetic/pharmacodynamic profile of a 30-day treatment with oral rivaroxaban.

Timepoint(s) of evaluation of this end point: During or within 2 days after stop of study treatment

Main Objective: to assess the incidence of major bleeding and clinically relevant non-major bleeding

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. At 31 Days

2. Day1 (post dose at 0.5-1.5h, 2.5-4h),day 15 (post dose at 2-8h) and day 30 (post dose at 10-16)

3. Day1 (post dose at 0.5-1.5h, 2.5-4h),day 15 (post dose at 2-8h) and day 30 (post dose at 10-16)

Secondary end point(s): 1. Composite of all recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging; results of pharmacokinetics (PK) / pharmacodynamics (PD).

2. Prothrombin time

3. Activated partial thromboplastin time

Secondary ID(s)

2014-000566-22-IE

BAY59-7939/14374

Source(s) of Monetary Support

Bayer HealthCare AG