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

• Register: EUCTR
• Last refreshed on: 29 January 2018
• Main ID: EUCTR2014-002385-74-AT
• Date of registration: 17/02/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer AG
• Public title: Rivaroxaban for treatment of venous or arterial blood clots in children from birth to less than 6 months
• Scientific title: 7-day study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in children from birth to less than 6 months with arterial or venous thrombosis. - EINSTEIN Junior Phase l/ll in children from birth to less than 6 months.
• Date of first enrolment: 30/03/2015
• Target sample size: 8
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002385-74
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; 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): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Canada, Finland, France, Germany, Israel, Italy, Netherlands, Poland, Spain, United States

Contacts

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

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

Key inclusion & exclusion criteria

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
Gestational age at birth of at least 37 weeks.
3. Hemoglobin, platelets 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.


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

Health Condition(s) or Problem(s) studied

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

Venous or arterial thrombosis

Intervention(s)

Product Name: Xarelto
Product Code: BAY59-7939
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02-8
Current Sponsor code: BAY59-7939
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Product Name: Xarelto
Product Code: BAY59-7939
Pharmaceutical Form: Oral suspension

Primary Outcome(s)

Main Objective: • to characterize the pharmacokinetic/pharmacodynamic profile of a 7-day treatment with oral rivaroxaban

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.

Secondary Objective: • to assess the incidence of major bleeding and clinically relevant non-major bleeding
• to assess the incidence of symptomatic recurrent thromboembolism and
• to assess asymptomatic deterioration in the thrombotic burden on repeat imaging

Timepoint(s) of evaluation of this end point: After last patient. last visit

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. After last patient, last visit
2. The analysis will primarily focus on bleeding that occurred during or within 2 days after stop of rivaroxaban
3. After last patient, last visit

Secondary end point(s): 1. The occurrence of recurrent venous or arterial thromboembolism and asymptomatic deterioration in thrombotic burden will be summarized.
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.
3. The occurrence of recurrent venous or arterial thromboembolism and asymptomatic deterioration in thrombotic burden

Secondary ID(s)

2014-002385-74-ES

BAY59-7939/17618

Source(s) of Monetary Support

Bayer AG