Safety of Dabigatran Etexilate in Blood Clot Prevention in Children

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02197416
• Date of registration: 21/07/2014
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
• Scientific title: 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
• Date of first enrolment: September 29, 2014
• Target sample size: 214
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02197416
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Mexico, Norway, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Secondary Prevention

Venous Thromboembolism

Intervention(s)

Drug: dabigatran etexilate

Primary Outcome(s)

Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 Months [Time Frame: At month 6 (Week 26) and month 12 (Week 52) of on treatment period]

Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months [Time Frame: At month 6 (Week 26) and 12 (Week 52) of on treatment period]

Event-free Probability of Mortality Overall and Related to Thrombotic or Thromboembolic Events at 6 and 12 Months [Time Frame: At month 6 (Week 26) and 12 (Week 52) of on treatment period]

Secondary Outcome(s)

Percentage of Participants With Dabigatran Etexilate (DE) Dose Adjustments During on Treatment Period [Time Frame: From first DE administration to 3 days of residual effect period after last DE administration, up to 52 weeks+ 3 days]

Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses) [Time Frame: At Visit 3 (day 4 after first dose of trial medication)]

Central Measurement of Ecarin Clotting Time (ECT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment) [Time Frame: Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.]

Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months [Time Frame: At month 6 (Week 26) and 12 (Week 52) of on treatment period]

Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment) [Time Frame: Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.]

Central Measurement of Diluted Thrombin Time (dTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment) [Time Frame: dTT values were collected at day 4, 22, 43, 85, 127, 183, 239, and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.]

Central Measurement of Diluted Thrombin Time (dTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses) [Time Frame: At Visit 3 (day 4 after first dose of trial medication)]

Central Measurement of Ecarin Clotting Time (ECT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses) [Time Frame: At Visit 3 (day 4 after first dose of trial medication)]

Secondary ID(s)

2014-000583-18

1160.108

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02197416