check_circleStudy Completed

Venous Thrombosis, Pediatrics

Bayer Identifier:

12892

ClinicalTrials.gov Identifier:

NCT01145859

EudraCT Number:

2009-017313-30

EU CT Number:

Not Available
Rivaroxaban pharmacokinetics/pharmacodynamics (PK/PD) study in Pediatric subjects

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.

Key Participants Requirements

Sex

Both

Age

6 - 18 Years
  • - 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
  • - 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
59
Trial Dates
November 2010 - July 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Lübeck, 23538, Germany
Completed
Los Angeles, 90027-6089, United States
Completed
Genova, 16147, Italy
Completed
Torino, 10126, Italy
Completed
Hamilton, L8N 3Z5, Canada
Completed
Edmonton, T6G 1C9, Canada
Completed
Ramat Gan, 5262000, Israel
Completed
Parkville, 3052, Australia
Completed
Wien, 1090, Austria
Completed
Chicago, 60611, United States
Terminated
Detroit, 48201-2196, United States
Completed
Jerusalem, 9112001, Israel
Terminated
Philadelphia, 19104, United States
Completed
Toronto, M5G 1X8, Canada
Terminated
Brisbane, 4029, Australia
Terminated
Cleveland, 44106-6007, United States
Terminated
Orange, 92868, United States
Terminated
Indianapolis, 46260, United States
Completed
Indianapolis, 46202, United States
Completed
Milano, 20122, Italy
Completed
TOULOUSE Cedex 9, 31059, France
Terminated
Crumlin, 12, Ireland
Completed
PARIS, 75015, France
Terminated
CLERMONT-FERRAND Cedex 1, 63003, France
Terminated
MONTPELLIER, 34059, France
Completed
Little Rock, 72202-3500, United States
Terminated
Basel, 4056, Switzerland
Terminated
St. Petersburg, 33701, United States
Completed
New Hyde Park, 11040, United States
Terminated
Linz, 4020, Austria
Terminated
Pittsburgh, 15224, United States
Terminated
Gainesville, 32610, United States
Terminated
Los Angeles, 90095, United States
Terminated
Durham, 27710, United States
Completed
Chapel Hill, 27514, United States
Terminated
Pavia, 27100, Italy

Primary Outcome

  • Pharmacokinetics parameters (AUC and Cmax)
    date_rangeTime Frame:
    From Day 1 to Day 2
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacodynamics parameters (PT, aPTT and anti-factor Xa)
    date_rangeTime Frame:
    From Day 1 to Day 2
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Safety and tolerability of rivaroxaban in pediatric subjects
    date_rangeTime Frame:
    Day 1, day 2 plus 7 days follow up
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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