Patients who are at risk of thromboembolic events (e.g., patients with thrombophilia, congenital heart disease, presence of a central venous catheter)
Conditions
Interventions
Trade Name: Lixiana (60 mg Film-coated tablet)
Product Name: Edoxaban tosylate
Product Code: DU-176b
Pharmaceutical Form: Film-coated tablet
Sponsors
Daiichi Sankyo , Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed assents (patients, when applicable) and ICFs (signed by parent/legal guardian) prior to participating in the study 2. Male or female patients 0 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History (within the last 6 months) of abnormal coagulation tests during screening, as defined by local laboratory reference ranges, which are not explained by anticoagulation therapy 2. Stroke where anticoagulant therapy is contraindicated 3. Patients with stage 2 hypertension defined as blood pressure confirmed > 99th percentile + 5 mmHg 4. Patients with renal function less than 50% of normal for age and size as determined by the National Kidney Disease Education Program version of the Schwartz formula8 5. Actively bleeding or has a high risk of bleeding 6. Has a currently active gastrointestinal ulceration or a known history of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding including bleeding from hemorrhoids) within the previous 6 months 7. Has known diabetic retinopathy 8. Has thrombocytopenia at screening ( 5 times the upper limit of normal (ULN) or total bilirubin > 2 times the ULN with direct bilirubin > 20% of the total 17. Patient is currently enrolled in another investigational device or drug study, or is receiving other investigational agents. Patients must have completed the prior clinical study at least 30 days prior to dosing 18. Patients of childbearing potential (post-menarche) who are sexually active and are not using approved contraception; who are pregnant (as based on test results); or are breastfeeding 19. Females with history of abnormal menses, including history of menorrhagia (heavy menstrual bleeding), metrorrhagia, or polymenorrhea 20. Patient has known sensitivity to the investigational product (IP) or any of its excipients 21. Positive drug or alcohol screen (excluding cotinine) at screening for patients 12 years of age or older, for newborns and for patients who are being breastfed 22. Patients who have received a transfusion or any blood products within 30 days prior to the first dose 23. Any major bleeding during prior anticoagulant therapy 24. Patients with any condition, that as judged by the Investigator, would place the patient at increased risk of harm if he/she participated in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the PK of Edoxaban in pediatric patients following oral single-dose administration.; Secondary Objective: - To evaluate the PD effects of edoxaban in pediatric patients following single-dose oral administration - To evaluate the safety and tolerability of single-dose oral administration of edoxaban in pediatric patients - To assess metabolite exposure (D21-2393, D21-3231, D21-1402, and D21-2135) in pediatric patients - To evaluate the palatability (bitterness, sweetness, and overall taste or aroma) of the liquid oral suspension of edoxaban ; Primary end point(s): - The PK endpoints will include PK parameters such as apparent systemic clearance (CL/F) and apparent volume of distribution (V/F). If data permit, derived PK parameters such as AUC and metabolite/parent ratios for AUCs will also be estimated. ; Timepoint(s) of evaluation of this end point: PK: - 0.25 to 1 hour postdose (1 sample) - 1.5 to 3 hours postdose (1 sample) - 3.5 to 6 hours postdose (1 sample) - 6.5 to 8 hours postdose (1 sample) - 8.5 to 14 hours postdose (1 sample) - 24 to 36 hours postdose (1 sample) - 48 to 54 hours postdose (1 sample) For subsequent age cohorts, emerging PK concentration-time data from completing patients will be analyzed on an ongoing basis and used to refine and optimize the PK blood sampling scheme (i.e., both the number of samples and the sampling windows). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The PD endpoints will include observed, change-from-baseline, and percent-change-from-baseline PT, aPTT, and anti-FXa. - Safety assessments will include: AEs, physical examination findings, vital signs, standard hematology, clinical chemistry, coagulation, and urinalysis laboratory tests. Note, urinalysis will be performed with plastic bags with a sticky strip from neonates and infants with diapers. - Palatability of the liquid formulation will be assessed using visual analog scale (VAS) scores. ; Timepoint(s) of evaluation of this end point: Coagulation: - Predose (1 sample) - 0.25 to 1 hour postdose (1 sample) - 1.5 to 3 hours postdose (1 sample) - 3.5 to 6 hours postdose (1 sample) - 6.5 to 8 hours postdose (1 sample) - 24 to 36 hours postdose (1 sample) All other secondary endpoints - throughout the study | — |
Countries
Canada, Egypt, France, Italy, Jordan, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Contact
Daiichi Sankyo, Inc.
Outcome results
None listed