Safety of Dabigatran Etexilate in Blood Clot Prevention in Children



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 18
Updated:4/4/2019
Start Date:September 29, 2014
End Date:February 28, 2020
Contact:Boehringer Ingelheim Call Center
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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Open Label, Single Arm Safety Prospective Cohort Study of Dabigatran Etexilate for Secondary Prevention of Venous Thromboembolism in Children From 0 to Less Than 18 Years

This open-label, single arm prospective cohort study will assess the safety of dabigatran
etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children
from 0 to less than 18 years of age will be eligible to participate.


Inclusion criteria:

- Male or female subjects 0 to less than 18 years of age at the time of informed consent
/ assent

- Previously documented objective diagnosis of VTE, followed by completed course of
initial VTE treatment for at least 3 months (in case of VKA - intended INR between 2
and 3) or completed study treatment (i.e. reached Visit 8) in the 1160.106 trial.
Patients, who during the treatment phase of 1160.106 trial were switched from
dabigatran etexilate to SOC arm for any reason, are not eligible for this study.

- Presence of an unresolved clinical risk factor requiring further anticoagulation for
secondary VTE prevention (e.g. central venous line, underlying disease, thrombophilia,
etc.)

- Written informed consent form (ICF) provided by the patient's parent or legal guardian
and assent provided by the patient (if applicable) at the time of ICF signature
according to local regulations.

- Further inclusion criteria apply

Exclusion criteria:

- Conditions associated with an increased risk of bleeding

- Renal dysfunction (eGFR < 50 mL/min/1.73m^2 using the Schwartz formula) or requirement
for dialysis. eGFR retesting during the screening period is allowed (once).

- Active infective endocarditis

- Subjects with a heart valve prosthesis requiring anticoagulation.

- Hepatic disease: Active liver disease, including known active hepatitis A, B or C or
Persistent alanine aminotransferase (ALT) or aspartate transaminase (AST) or alkaline
phosphatase (AP) > 3 × upper limit of normal (ULN) within 3 months of screening

- Pregnant or breast feeding females. Females who have reached menarche and are not
using an acceptable method of birth control, or do not plan to continue using this
method throughout the study and / or do not agree to adhere to pregnancy testing
required by this protocol

- Patients in age group 0 to < 2 years with gestational age at birth < 37 weeks or with
body weight lower than the 3rd percentile

- Anemia (hemoglobin < 80g/L) or thrombocytopenia (platelet count < 80 x 109/L) at
screening. Transfusions during the screening period are allowed, provided that a
satisfactory hemoglobin or platelet level is attained prior to visit 2

- Patients who have taken restricted medication prior to first dose of study medication

- Patients who have received an investigational drug in the past 30 days prior to
screening, except patients who have completed the treatment period (up to Visit 8) in
1160.106 trial

- Patients who are allergic/sensitive to any component of the study medication including
solvent

- Patients or parents/legal guardians considered unreliable to participate in the trial
per investigator judgment or any condition which would present a safety hazard to the
patient based on investigator judgment

- Further exclusion criteria apply
We found this trial at
14
sites
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1200 Pleasant Street
Des Moines, Iowa 50309
(515) 241-KIDS
Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
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Des Moines, IA
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Charlottesville, VA
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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Las Vegas, Nevada 89109
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Las Vegas, NV
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2450 Riverside Avenue
Minneapolis, Minnesota 55454
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Minneapolis, MN
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Pittsburgh, PA
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
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Sacramento, CA
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Saint Louis, Missouri 63104
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Saint Louis, MO
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101 W 8th Ave
Spokane, Washington 99204
(509) 474-3131
Providence Sacred Heart Medical Center & Children's Hospital When Mother Joseph and the Sisters of...
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Spokane, WA
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from
Tampa, FL
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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from
Winston-Salem, NC
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