Single-dose study testing a rivaroxaban granules to be diluted into an oral suspension in children from 2 months to 12 years with previous blood clot

• Register: EUCTR
• Last refreshed on: 25 June 2018
• Main ID: EUCTR2015-000962-76-FI
• Date of registration: 10/07/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer AG
• Public title: Single-dose study testing a rivaroxaban granules to be diluted into an oral suspension in children from 2 months to 12 years with previous blood clot
• Scientific title: Single-dose study testing a rivaroxaban granules for oral suspension formulation in children from 2 months to 12 years with previous thrombosis - Phase 1 granules for oral suspension
• Date of first enrolment: 26/08/2015
• Target sample size: 58
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000962-76
• 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
• 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, Belgium, Canada, Finland, France, Hungary, Ireland, Italy, Spain, Sweden, 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. For group A and B:
Children with an age between 6 months and <12 years who have completed
anticoagulant treatment at least 10 days prior to the planned study drug
administration
For Group C:
Children with an age =2 months and weight between 3 and <12 kg, who have
completed anticoagulant treatment at least 10 days prior to the planned study
drug administration.
? Gestational age at birth of at least 37 weeks
? Oral feeding/ nasogastric/ gastric feeding for at least 10 days 29
For Groups A, B and C:
2. Normal PT and aPTT within 10 days prior to planned study drug administration
3. Written informed consent provided and, if applicable, child assent provided
Are the trial subjects under 18? yes
Number of subjects for this age range: 58
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:
For Groups A, B and C:
1. Active bleeding or high risk for bleeding, contraindicating anticoagulant therapy
2. Planned invasive procedures, including removal of central lines, within 24 hours before and after single dose intake
3. An estimate glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
4. Hepatic disease which is associated either with:
? 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.
5. Platelet count < 50 x 109/L
6. Hypertension (defined as systolic and/or diastolic blood pressure >95th percentile for age)
7. Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, e.g.,
all human immunodeficiency virus protease inhibitors and the following azoleantimycotic agents: ketoconazole, itraconazole, voriconazole, and posaconazole, if used systemically (fluconazole is allowed)
8. Concomitant use of strong inducers of CYP3A4, e.g., rifampicin, rifabutin,
phenobarbital, phenytoin and carbamazepine
9. Inability to cooperate with the study procedures
10. Hypersensitivity to rivaroxaban
11. Participation in a study with an investigational drug other than rivaroxaban or a medical device within 30 days prior to treatment
For Group C only:
12. History of gastrointestinal disease or surgery associated with impaired absorption


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

Health Condition(s) or Problem(s) studied

Thrombosis
MedDRA version: 19.1 Level: PT Classification code 10043607 Term: Thrombosis System Organ Class: 10047065 - Vascular disorders

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

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-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: For Group A and B
Depending on age, PK samples are collected at several time points within 24 hours after drug administration

For Group C
PK samples are collected at several time points within 28 hours after drug administration

Primary end point(s): The primary variables for pharmacokinetics will be the standard pharmacokinetic (PK) parameters for exposure, area under the curve (AUC) and Cmax, derived via population PK approaches.

Secondary Objective: • To document safety and tolerability in terms of AEs observed
after administration of the rivaroxaban granules for oral
suspension formulation

Main Objective: • To characterize the pharmacokinetic profile of rivaroxaban
administered as granules for oral suspension

Secondary Outcome(s)

Secondary end point(s): The principal safety outcome is the composite of major bleeding and clinically relevant non-major bleeding.

Timepoint(s) of evaluation of this end point: At 24 hrs after drug administration with additional followup on day 8 (+3) days.

Secondary ID(s)

17992

2015-000962-76-AT

Source(s) of Monetary Support

Bayer AG