check_circleStudy Completed

thromboembolism

Bayer Identifier:

17618

ClinicalTrials.gov Identifier:

NCT02564718

EudraCT Number:

2014-002385-74

EU CT Number:

Not Available
Rivaroxaban for treatment in venous or arterial thrombosis in neonates

Trial purpose

The purpose of this study is to find out whether rivaroxaban is safe and effective to use in children age newborn to less than 6 months and how long it stays in the body and how it is used in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.

Key Participants Requirements

Sex

Both

Age

0 - 6 Months
  • - 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.
    - Hemoglobin, platelets, creatinine, ALT and total and direct bilirubin assessed within 10 days prior to enrollment.
    - Oral feeding/nasogastric/gastric feeding for at least 10 days.
    - Informed consent provided.
    - Body weight >2600 g
  • - Active bleeding or high risk for bleeding
    contraindicating anticoagulant therapy, including history of intra-ventricular bleeding.
    - Symptomatic progression of thrombosis during preceding anticoagulant treatment.
    - Planned invasive procedures, including lumbar puncture and removal of non-peripherally placed central lines during study treatment.
    - 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.
    - Creatinine >1.5 times of normal.
    - Uncontrolled Hypertension defined as >95th percentile.
    - History of gastrointestinal disease or surgery associated with impaired absorption.
    - Platelet count <100 x 109/L.
    - 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)
    - Concomitant use of strong inducers of CYP3A4, e.g. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
    - Indication for anticoagulant therapy other than current thrombosis.
    - Indication for antiplatelet therapy or non-steroid anti-inflammatory drug (NSAID) therapy. Incidental use is allowed.
    - Hypersensitivity to rivaroxaban or its excipients.
    - Participation in a study with an investigational drug or medical device within 30 days prior to enrollment.

Trial summary

Enrollment Goal
10
Trial Dates
November 2015 - December 2017
Phase
Phase 1/Phase 2
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Valencia, 46026, Spain
Withdrawn
A Coruña, 15006, Spain
Completed
Barcelona, 08035, Spain
Completed
Madrid, 28007, Spain
Completed
Ramat Gan, 5262000, Israel
Withdrawn
Jerusalem, 9112001, Israel
Withdrawn
Haemek Medical CenterAFula, Israel
Withdrawn
Parkville, 3052, Australia
Withdrawn
Torino, 10126, Italy
Withdrawn
Padova, 35128, Italy
Completed
Milano, 20122, Italy
Withdrawn
Medizinische Universität GrazGraz, 8036, Austria
Withdrawn
Los Angeles, 90027-6089, United States
Withdrawn
Philadelphia, 19104, United States
Completed
MONTPELLIER, 34059, France
Withdrawn
Indianapolis, 46202, United States
Withdrawn
Fort Worth, 76104, United States
Withdrawn
NIJMEGEN, 6500 HB, Netherlands
Completed
Wien, 1090, Austria
Withdrawn
Charlotte, 28207, United States
Withdrawn
ROTTERDAM, 3015 GJ, Netherlands
Withdrawn
Hamilton, L8N 3Z5, Canada
Withdrawn
Frankfurt, 60596, Germany
Withdrawn
Essen, 45147, Germany
Withdrawn
Berlin, 13353, Germany
Withdrawn
BORDEAUX, 33000, France
Withdrawn
Gdansk, 80-952, Poland
Withdrawn
Kansas City, 64108, United States
Withdrawn
New York, 10032, United States
Withdrawn
Durham, 27710, United States
Withdrawn
St. Petersburg, 33701, United States
Withdrawn
Ottawa, K1H 8L1, Canada
Completed
Izmir, 35-100, Turkey
Withdrawn
Zürich, 8032, Switzerland
Withdrawn
Bern, 3010, Switzerland
Withdrawn
Erlangen, 91054, Germany
Withdrawn
Lausanne, 1011, Switzerland
Withdrawn
Chicago, 60611, United States
Withdrawn
Chicago, 60611, United States
Withdrawn
Berlin, 13353, Germany
Withdrawn
Seoul, 135-710, Korea, Republic Of
Withdrawn
Seoul, 03080, Korea, Republic Of
Completed
Madrid, 28046, Spain
Withdrawn
Darmstadt, 64283, Germany
Withdrawn
Seoul, 120-752, Korea, Republic Of
Completed
Erlangen, 91052, Germany
Withdrawn
Gainesville, 32610, United States
Withdrawn
Tampere, 33521, Finland

Primary Outcome

  • Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1
    Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.
    date_rangeTime Frame:
    30 minutes to 1.5 hours post-dose; 2 to 4 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 1 (tid dosing)
    enhanced_encryption
    Safety Issue:
    No
  • Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3
    Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.
    date_rangeTime Frame:
    2 to 8 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 3 (tid dosing)
    enhanced_encryption
    Safety Issue:
    No
  • Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 8
    Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.
    date_rangeTime Frame:
    10 to 16 hours post-dose on Day 8 (bid dosing)
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Prothrombin Time at Day 1
    Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.
    date_rangeTime Frame:
    10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Prothrombin Time at Day 3
    Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.
    date_rangeTime Frame:
    10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 1
    The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII.
    date_rangeTime Frame:
    10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 3
    The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII.
    date_rangeTime Frame:
    10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)
    enhanced_encryption
    Safety Issue:
    No
  • Anti-factor Xa Activity (anti-Xa) Values at Day 1
    The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.
    date_rangeTime Frame:
    2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)
    enhanced_encryption
    Safety Issue:
    No
  • Anti-factor Xa Activity (anti-Xa) Values at Day 3
    The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.
    date_rangeTime Frame:
    2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)
    enhanced_encryption
    Safety Issue:
    No
  • Anti-factor Xa Activity (anti-Xa) Values at Day 8
    The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.
    date_rangeTime Frame:
    10-16 hours post-dose on Day 8 (both bid and tid dosing)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events
    Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and •associated with a fall in hemoglobin of 2 gram/deciliter (g/dL) or more, •leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or •occurring in a critical site, example: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or •contributing to death. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with: •medical intervention, or •unscheduled contact (visit or telephone call) with a physician, or •cessation (temporary) of study treatment, or •discomfort for the child such as pain
    date_rangeTime Frame:
    From start of study drug administration until 30-day post study treatment period
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging
    Symptomatic recurrence of thromboembolism and asymptomatic deterioration was documented using the appropriate imaging test and confirmed by CIAC which was unaware of treatment assignment. Asymptomatic deterioration in thrombotic burden on repeat imaging, as assessed by the CIAC. Adjudication results were the basis for the final analyses.
    date_rangeTime Frame:
    From start of study drug administration until 30-day post study treatment period
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
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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