Safety of Dabigatran Etexilate in Blood Clot Prevention in Children

Phase 3

Completed

Conditions: Secondary Prevention
Venous Thromboembolism

Interventions: Drug: dabigatran etexilate

Registration Number: NCT02197416

Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 214

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dabigatran etexilate	dabigatran etexilate	-

Primary Outcome Measures

Name	Time	Method
Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months	At month 6 (Week 26) and 12 (Week 52) of on treatment period	The event-free probability of first recurrence of VTE were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience recurrent VTE at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-VTE related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 Months	At month 6 (Week 26) and month 12 (Week 52) of on treatment period	The event-free probability of major or minor (including CRNM) bleeding event were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience major or minor (including CRNM) bleeding event at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-bleeding related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Event-free Probability of Mortality Overall and Related to Thrombotic or Thromboembolic Events at 6 and 12 Months	At month 6 (Week 26) and 12 (Week 52) of on treatment period	The event-free probability of mortality overall and related to thrombotic or thromboembolic events were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience mortality overall and related to thrombotic or thromboembolic events at the time of analysis, dropped out from the trial early, were lost to follow-up, were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.

Secondary Outcome Measures

Name	Time	Method
Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months	At month 6 (Week 26) and 12 (Week 52) of on treatment period	The event-free probability of PTS were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience PTS at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-PTS related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Percentage of Participants With Dabigatran Etexilate (DE) Dose Adjustments During on Treatment Period	From first DE administration to 3 days of residual effect period after last DE administration, up to 52 weeks+ 3 days	Percentage of participants with dabigatran etexilate dose adjustments during on treatment period. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)	At Visit 3 (day 4 after first dose of trial medication)
Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)	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 Ecarin Clotting Time (ECT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)	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)	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 Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)	At Visit 3 (day 4 after first dose of trial medication)
Central Measurement of Diluted Thrombin Time (dTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)	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.

Trial Locations

Locations (62): University of California Davis
🇺🇸
Sacramento, California, United States
University of Miami
🇺🇸
Miami, Florida, United States
St. Joseph's Children's Hospital
🇺🇸
Tampa, Florida, United States
University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States
Boston Children's Hospital
🇺🇸
Boston, Massachusetts, United States
Alliance for Childhood Diseases
🇺🇸
Las Vegas, Nevada, United States
Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
University of Virginia Health System
🇺🇸
Charlottesville, Virginia, United States
Providence Sacred Heart Medical Center and Children's Hospital
🇺🇸
Spokane, Washington, United States
AKH - Medical University of Vienna
🇦🇹
Wien, Austria
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University of California Davis
🇺🇸Sacramento, California, United States