Trial Search Results

Hokusai Study in Pediatric Patients 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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Daiichi Sankyo, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Edoxaban
  • Drug: Standard of Care

Phase:

Phase 3

Eligibility


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.

Ages Eligible for Study

N/A - 17 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Site Coordinator
650-723-5535
Recruiting