Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 17
Updated:2/14/2019
Start Date:March 27, 2017
End Date:March 2021

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A Phase 3, Open-label, Randomized, Multi-center, Controlled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed Venous Thromboembolism (VTE)

This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint
evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is
designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to
compare the efficacy and safety of edoxaban against standard of care in pediatric subjects
with confirmed VTE.

The objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC;
including low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic
pentasaccharide (SP) Xa inhibitors) in the treatment and secondary prevention of VTE in
pediatric subjects with regard to the composite efficacy endpoint (ie, symptomatic recurrent
VTE, death as result of VTE, and no change or extension of thrombotic burden) during the
first 3-month treatment period.

Inclusion Criteria:

1. Male or female pediatric subjects between birth (defined as 38 weeks gestational age)
and less than 18 years of age at the time of consent.

2. Pediatric subjects with the presence of documented VTE confirmed by appropriate
diagnostic imaging and requiring anticoagulant therapy for at least 90 days.

3. Subjects must have received at least 5 days of heparin therapy prior to randomization
to treat the newly identified index VTE. In addition, prior to being randomized to
edoxaban or SOC, subjects initially treated with VKA are recommended to have an
international normalized ratio (INR) < 2.0.

4. Subject and/or parent(s)/legal guardian(s) or legally acceptable representative is
informed and provides signed consent for the child to participate in the study.

5. Female subjects who have menarche must test negative for pregnancy at Screening and
must consent to avoid becoming pregnant by using an approved contraception method
throughout the study.

Exclusion Criteria:

1. Subjects with active bleeding or high risk of bleeding contraindicating treatment with
LMWH, SP Xa inhibitors, VKAs, or direct oral anticoagulants (DOACs; identified high
risk of bleeding during prior experimental administration of DOACs).

2. Subjects who have been or are being treated with thrombolytic agents, thrombectomy or
insertion of a caval filter for the newly identified index VTE.

3. Administration of antiplatelet therapy is contraindicated in both arms except for low
dose aspirin defined as 1-5 mg/Kg/day with maximum of 100 mg/day.

4. Administration of rifampin is prohibited during the study and subjects on concomitant
use of rifampin are excluded.

5. Subjects with hepatic disease associated with coagulopathy leading to a clinically
relevant bleeding risk (aPTT > 50 seconds or international normalized ratio [INR] >
2.0 not related to anticoagulation therapy) or alanine aminotransferase (ALT) > 5 ×
the upper limit of normal (ULN) or total bilirubin > 2 × ULN with direct bilirubin >
20% of the total at Screening Visit.

6. Subjects with glomerular filtration rate (GFR) < 30% of normal for age and size as
determined by the Schwartz formula.

7. Subjects with stage 2 hypertension defined as blood pressure (BP) systolic and/or
diastolic confirmed > 99th percentile + 5 mmHg.

8. Subject with thrombocytopenia < 50 × 109/L at Screening Visit. Subjects with a history
of heparin-induced thrombocytopenia may be enrolled in the study at the Investigator's
discretion.

9. Life expectancy less than the expected study treatment duration (3 months).

10. Subjects who are known to be pregnant or breastfeeding.

11. Subjects with any condition that, as judged by the Investigator, would place the
subject at increased risk of harm if he/she participated in the study, including
contraindicated medications.

12. Subjects who participated in another clinical study or treated with an experimental
therapy with less than a 30 day washout period prior to identifying the qualifying
index VTE.
We found this trial at
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Phone: 252-744-4773
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Chapel Hill, North Carolina 27599
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Phone: 901-595-2097
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
Phone: 305-243-6925
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Phone: 813-259-8813
University of South Florida The University of South Florida is a high-impact, global research university...
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4230 Teniente General Juan Domingo Perón
Buenos Aires, C1199
Phone: +54 92916483724
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200 Hawthorne Ln
Charlotte, North Carolina 28204
(704) 384-4000
Phone: 704-384-5369
Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
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Charlotte, North Carolina 28204
Phone: 980-442-2356
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-563-1883
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Grand Rapids, Michigan 49503
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Indianapolis, Indiana 46260
Phone: 317-871-0011
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10833 Le Conte Avenue
Los Angeles, California 90095
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Phone: 502-629-5820
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Memphis, Tennessee 38103
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Phone: 414-266-3360
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Minneapolis, Minnesota 55404
Phone: 612-813-6969
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Oak Lawn, Illinois 60453
Phone: 708-684-4576
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Phone: 405-271-3661
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Providence, Rhode Island 02903
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-454-6147
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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300 Pasteur Dr
Stanford, California 94305
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Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Tucson, Arizona 85742
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