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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01895777
First received: July 4, 2013
Last updated: September 18, 2017
Last verified: September 2017
  Purpose
This open-label, randomized, parallel-group, active-controlled, multi-centre non-inferiority study of dabigatran etexilate versus standard of care in children from birth to less than 18 years of age will assess the efficacy and safety of dabigatran relative to low molecular weight heparins or vitamin K antagonists for treatment of VTE. This study will also assess the appropriateness of the proposed dabigatran doses for use in paediatric patients using three different formulations of dabigatran (capsules, pellets and oral liquid formulation)

Condition Intervention Phase
Venous Thromboembolism Drug: dabigatran etexilate Drug: standard of care Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • First component of the co-primary endpoint: A combined efficacy endpoint of complete thrombus resolution plus freedom from recurrent VTE plus freedom from mortality related to VTE [ Time Frame: 12 weeks ]
  • Second component of the co-primary endpoint: Freedom from major bleeding events (a safety endpoint) [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Pharmacokinetic assessments (plasma concentrations of total dabigatran) 3 days after start of treatment (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 ]
  • Frequency of dose adjustments [ Time Frame: 12 weeks ]
  • 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 ]
  • Assessment of the acceptability of an age-appropriate formulation at end of therapy [ Time Frame: 3 weeks and 12 weeks ]
  • All bleeding events [ Time Frame: 12 weeks ]
  • All-cause mortality [ Time Frame: 12 weeks ]
  • All components of the primary efficacy endpoints [ Time Frame: 12 weeks ]
  • Pharmacodynamic assessments (aPTT, ecarin clotting time (ECT) and dTT) 3 days after start of treatment (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 ]
  • Frequency of temporary discontinuation from therapy [ Time Frame: 12 weeks ]
  • Frequency of permanent discontinuation from therapy [ Time Frame: 12 weeks ]
  • Number of laboratory monitoring requirements for dose adjustment during the treatment phase [ Time Frame: 12 weeks ]
  • Freedom from thrombus progression at end of therapy (day 84 after randomisation or eEOT, whichever comes first) [ Time Frame: 12 weeks ]

Estimated Enrollment: 180
Actual Study Start Date: September 25, 2013
Estimated Study Completion Date: June 29, 2018
Estimated Primary Completion Date: June 29, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 or vitamin K antagonist 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 or vitamin K antagonist prescribed in an open label fashion for 3 months (these medications will not supplied in this study as IMP)

  Eligibility

Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 < 60 mL/min/1.73m2 for patients aged 12 to < 18 years or eGFR < 80 mL/min/1.73m2 for patients aged 0 to < 12 years 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895777

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 77 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01895777     History of Changes
Other Study ID Numbers: 1160.106
2013-002114-12 ( EudraCT Number )
Study First Received: July 4, 2013
Last Updated: September 18, 2017

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dabigatran
Heparin, Low-Molecular-Weight
Dalteparin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on September 21, 2017