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

  • STATUS
    Recruiting
  • End date
    Dec 28, 2021
  • participants needed
    274
  • sponsor
    Daiichi Sankyo, Inc.
Updated on 28 January 2021
heparin
anticoagulants
vitamin k antagonist
anticoagulant therapy
probe
vitamin k
venous thromboembolism
thromboembolism
edoxaban
heparin therapy

Summary

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.

Description

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.

Details
Condition Pulmonary Disease, Venous Thrombosis, Venous Thromboembolism, Pulmonary Embolism, Thromboembolism, Thrombosis, Blood Clots, Lung Disease, Deep Vein Thrombosis, deep venous thrombosis of lower extremity, deep venous thrombosis, lung embolism
Treatment Standard of Care, Edoxaban
Clinical Study IdentifierNCT02798471
SponsorDaiichi Sankyo, Inc.
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 17 yrs?
Gender: Male or Female
Do you have any of these conditions: Venous Thrombosis or Pulmonary Embolism or Venous Thromboembolism or Pulmonary Disease or Thromboembolism or Blood Clots or Deep Vein Thrombosis or Th...?
Do you have any of these conditions: deep venous thrombosis or deep venous thrombosis of lower extremity or Venous Thromboembolism or Pulmonary Embolism or Lung Disease or Deep Vein Throm...?
Do you have any of these conditions: Lung Disease or Venous Thrombosis or lung embolism or Venous Thromboembolism or deep venous thrombosis or Blood Clots or Pulmonary Disease or Deep Vei...?
Do you have any of these conditions: lung embolism or Pulmonary Embolism or Thrombosis or deep venous thrombosis of lower extremity or Thromboembolism or Venous Thromboembolism or Venous ...?
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
Pediatric subjects with the presence of documented VTE confirmed by appropriate diagnostic imaging and requiring anticoagulant therapy for at least 90 days
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
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
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

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)
Subjects who have been or are being treated with thrombolytic agents, thrombectomy or insertion of a caval filter for the newly identified index VTE
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
Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded
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
Subjects with glomerular filtration rate (GFR) < 30% of normal for age and size as determined by the Schwartz formula
Subjects with stage 2 hypertension defined as blood pressure (BP) systolic and/or diastolic confirmed > 99th percentile + 5 mmHg
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
Life expectancy less than the expected study treatment duration (3 months)
Subjects who are known to be pregnant or breastfeeding
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
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
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