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Safety of Dabigatran Etexilate in Blood Clot Prevention in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02197416
Recruitment Status : Completed
First Posted : July 22, 2014
Last Update Posted : November 21, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Secondary Prevention Drug: dabigatran etexilate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : September 29, 2014
Actual Primary Completion Date : October 16, 2019
Actual Study Completion Date : November 19, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: dabigatran etexilate Drug: dabigatran etexilate
Age and weight appropriate capsule dose (combination of 50 mg, 75 mg and 110 mg capsules) or pellets or oral liquid formulation

Primary Outcome Measures :
  1. Recurrence of venous thromboembolism (VTE) [ Time Frame: 6 and 12 months ]
  2. Major and minor (including clinically relevant non-major (CRNM)) bleeding events [ Time Frame: 6 and 12 months ]
  3. Mortality overall and related to thrombotic or thromboembolic events [ Time Frame: 6 and 12 months ]

Secondary Outcome Measures :
  1. Number of dabigatran etexilate dose adjustments during treatment period [ Time Frame: 12 months ]
  2. Occurrence of post-thrombotic syndrome (PTS) [ Time Frame: 6 and 12 months ]
  3. Central measurement of aPTT (Activated partial thromboplastin time) at Visit 3 (after at least six consecutive dabigatran etexilate doses) and after at least 3 days following any dabigatran etexilate dose adjustment [ Time Frame: Up to 365 days ]
  4. Central measurement of ECT (Ecarin clotting time) at Visit 3 (after at least six consecutive dabigatran etexilate doses) and after at least 3 days following any dabigatran etexilate dose adjustment [ Time Frame: Up to 365 days ]
  5. Central measurement of dTT (Diluted Thrombin Time)(Anti-Factor IIa) at Visit 3 (after at least six consecutive dabigatran etexilate doses) and after at least 3 days following any dabigatran etexilate dose adjustment [ Time Frame: Up to 365 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02197416

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Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim Identifier: NCT02197416    
Other Study ID Numbers: 1160.108
2014-000583-18 ( EudraCT Number )
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Neoplasm Metastasis
Venous Thromboembolism
Neoplastic Processes
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action