Phase 3
Completed N=213
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
Venous Thromboembolism · Secondary Prevention
Source: ClinicalTrials.gov NCT02197416 ↗
Enrolled (actual)
213
Serious AEs
14.1%
Results posted
Jun 2020
Primary outcomePrimary: Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months — 1.000; 1.000; 0.979; 1.000 Probability
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months |
1.000; 1.000; 0.979; 1.000; 1.000; 0.979 | — |
| PRIMARY Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 Months |
0.889; 0.894; 0.753; 0.889; 0.831; 0.691 | — |
| PRIMARY Event-free Probability of Mortality Overall and Related to Thrombotic or Thromboembolic Events at 6 and 12 Months |
1.000; 1.000; 1.000; 1.000; 1.000; 1.000 | — |
| SECONDARY Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months |
1.000; 1.000; 0.979; 1.000; 1.000; 0.979 | — |
| SECONDARY Percentage of Participants With Dabigatran Etexilate (DE) Dose Adjustments During on Treatment Period |
66.7; 39.5; 21.1 | — |
| SECONDARY Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses) |
46.6; 57.1; 56.8 | — |
| SECONDARY Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment) |
49.1; 57.3; 59.0 | — |
| SECONDARY Central Measurement of Ecarin Clotting Time (ECT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses) |
52.7; 64.3; 69.5 | — |
| SECONDARY Central Measurement of Ecarin Clotting Time (ECT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment) |
53.3; 66.6; 69.2 | — |
| SECONDARY Central Measurement of Diluted Thrombin Time (dTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses) |
37.9; 40.5; 45.3 | — |
| SECONDARY Central Measurement of Diluted Thrombin Time (dTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment) |
40.0; 46.0; 43.4 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT02197416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.