Trial Condition(s):
Venous thrombosis, Pediatrics
Rivaroxaban pharmacokinetics/pharmacodynamics (PK/PD) study in Pediatric subjects
Bayer Identifier:
12892
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.
Inclusion Criteria
- Pediatric subjects > 6 months and < 18 years of age at the time of administration of study drug. - Patients who have completed treatment of VTE, but are considered to have risk for recurrence of VTE
Exclusion Criteria
- Any major or clinically relevant bleeding during prior VTE treatment - Abnormal coagulation tests within 7 days prior to study drug administration - Severe renal impairment - Planned invasive procedures prior to or after 24 hours of study drug administration
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Lübeck, Germany, 23538 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90027-6089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16147 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torino, Italy, 10126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamilton, Canada, L8N 3Z5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Edmonton, Canada, T6G 1C9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Parkville, Australia, 3052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Detroit, United States, 48201-2196 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5G 1X8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brisbane, Australia, 4029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44106-6007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Orange, United States, 92868 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Indianapolis, United States, 46260 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Indianapolis, United States, 46202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site TOULOUSE Cedex 9, France, 31059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Crumlin, Ireland, 12 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75015 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CLERMONT-FERRAND Cedex 1, France, 63003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONTPELLIER, France, 34059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Little Rock, United States, 72202-3500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Basel, Switzerland, 4056 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, United States, 33701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Hyde Park, United States, 11040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15224 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gainesville, United States, 32610 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90095 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durham, United States, 27710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chapel Hill, United States, 27514 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Single-dose pilot study of oral rivaroxaban in pediatric subjects with venous thromboembolism
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Pharmacokinetics parameters (AUC and Cmax)Timeframe: From Day 1 to Day 2
- Pharmacodynamics parameters (PT, aPTT and anti-factor Xa)Timeframe: From Day 1 to Day 2
Secondary Outcome
- Safety and tolerability of rivaroxaban in pediatric subjectsTimeframe: Day 1, day 2 plus 7 days follow up
Additional Information
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