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Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)

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: NCT01895777
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : November 21, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: dabigatran etexilate Drug: standard of care Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Randomized, Parallel-group, Active-controlled, Multi-centre Non-inferiority Study of Dabigatran Etexilate Versus Standard of Care for Venous Thromboembolism Treatment in Children From Birth to Less Than 18 Years of Age
Actual Study Start Date : September 25, 2013
Actual Primary Completion Date : October 16, 2019
Actual Study Completion Date : November 14, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: dabigatran etexilate
Dabigatran etexilate capsules, pellets or liquid formulation given BID in an open label fashion for 3 months
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

Active Comparator: standard of care
Low molecular weight heparin, vitamin K antagonist or fondaparinux prescribed in an open label fashion for 3 months (these medications will not supplied in this study as IMP)
Drug: standard of care
Low molecular weight heparin, vitamin K antagonist or fondaparinux prescribed in an open label fashion for 3 months (these medications will not supplied in this study as IMP)

Primary Outcome Measures :
  1. A combined efficacy endpoint of complete thrombus resolution plus freedom from recurrent VTE plus freedom from mortality related to VTE [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Cpre,ss (pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose) taken at 10 to 16 hours after the last dose (trough) [ Time Frame: 3, 7, 21, 42, 63 and 84 days ]
  2. Frequency of dose adjustments [ Time Frame: 12 weeks ]
  3. Frequency of switch of type of anti-coagulation therapy (including dabigatran to SOC) and a switch from an intended standard of care treatment to another [ Time Frame: 12 weeks ]
  4. Assessment of the acceptability of an age-appropriate formulation at end of therapy [ Time Frame: 3 weeks and 12 weeks ]
  5. All bleeding events [ Time Frame: 12 weeks ]
  6. All-cause mortality [ Time Frame: 12 weeks ]
  7. All components of the primary efficacy endpoints [ Time Frame: 12 weeks ]
  8. Pharmacodynamic assessments (aPTT, ecarin clotting time (ECT) and diluted thrombin time (dTT)(Anti-Factor IIa activity)) at visit 3 (after at least six consecutive dabigatran doses) and after 3 days following any dabigatran dose adjustment [ Time Frame: 3, 7, 21, 42, 63 and 84 days ]
  9. Frequency of temporary discontinuation from therapy [ Time Frame: 12 weeks ]
  10. Frequency of permanent discontinuation from therapy [ Time Frame: 12 weeks ]
  11. Number of subjects with laboratory monitoring requirements for dose adjustment during the treatment phase [ Time Frame: 12 weeks ]
  12. Freedom from thrombus progression at end of therapy (day 84 after randomisation or eEOT, whichever comes first) [ Time Frame: 12 weeks ]
  13. Freedom from major bleeding events (a safety endpoint) [ Time Frame: 12 weeks ]
  14. C2,ss (concentration of the analyte in plasma at steady state at 2 hours after administration of the last dose) taken at 1 to 3 hours after the last dose (peak) [ Time Frame: 3, 7, 21, 42, 63 and 84 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
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
  • Documented diagnosis of clinically stable VTE (e.g. DVT, PE, central line thrombosis, sinus vein thrombosis) per investigator judgment, initially treated (minimum of 5 to 7 days, but not longer than 21 days) with parenteral anticoagulation therapy, such as unfractionated heparin (UFH) or a low molecular weight heparin (LMWH).
  • Clinical indication for at least 3 month of treatment with anticoagulants for the VTE episode defined under the above inclusion criterion.
  • Written informed consent provided by the patient's parent or legal guardian and assent provided by the patient (if applicable) at the time of informed consent form (ICF) signature according to local regulations.

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 a medically accepted contraceptive method per local guidelines. Acceptable methods of birth control must be used in a correct and consistent manner
  • Patients in stratum 3 (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 prohibited or restricted medication within one week of the first dose of study medication other than medication for prior VTE treatment and P-glycoprotein inhibitors..
  • Patients who have received an investigational drug in the past 30 days prior to screening
  • 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
  • Patients or parents/legal guardians who are unwilling or unable to undergo or permit repeat of the baseline imaging tests required to confirm thrombus resolution at study day 84 (or eEOT, whichever comes first) or in whom repeating such imaging tests at these pre-specified time points may not be medically in the patient's best interest. Examples may include unwarranted radiation exposure as a result of a repeat CT scan at day 84 for a patient with an isolated case of pulmonary embolism evaluated at baseline solely by a CT scan. In such cases, the baseline radiological assessment (e.g. CT) may be supplemented with an acceptable non-radiological assessment at baseline (e.g. MRI) which could then be repeated at day 84 hence alleviating any potential unwarranted radiation exposure.
  • 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): NCT01895777

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Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim Identifier: NCT01895777    
Other Study ID Numbers: 1160.106
2013-002114-12 ( EudraCT Number )
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action