Safety and Tolerability of Dabigatran Etexilate in Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00844415
First received: February 13, 2009
Last updated: June 3, 2014
Last verified: December 2013
  Purpose

To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.


Condition Intervention Phase
Venous Thromboembolism
Drug: dabigatran etexilate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given for 3 Days at the End of Standard Anticoagulant Therapy in Children Aged 12 Years to Less Than 18 Years

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of Patients With Bleeding Events (Major and Minor) [ Time Frame: From Screening until 30 days after first drug administration (end of trial visit) ] [ Designated as safety issue: Yes ]

    Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria:

    Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds.


  • Number of Patients With Adverse Events [ Time Frame: From Screening until 30 days after first drug administration (end of trial visit) ] [ Designated as safety issue: No ]
    Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period. Events were considered "on-treatment" if occurring within 72 hours after last drug administration.

  • Plasma Concentration of Free Dabigatran [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Plasma concentration of free dabigatran measured at 72 hours after first dose

  • Plasma Concentration of Total Dabigatran [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Plasma concentration of total dabigatran measured at 72 hours after first dose

  • Thrombin Time (TT) Centrally Measured [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.

  • TT Locally Measured [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.


Secondary Outcome Measures:
  • Activated Partial Thromboplastin Time (aPTT) Centrally Measured [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Measurement of aPTT was performed locally and centrally using validated assays.

  • aPTT Locally Measured [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Measurement of aPTT was performed locally and centrally using validated assays.

  • Ecarin Clotting Time (ECT) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT.

  • Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs [ Time Frame: Baseline and 3 days ] [ Designated as safety issue: No ]
    Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.

  • Occurences of Clinical Outcome [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Occurrences of clinical outcomes including recurrent venous thrombolic event (VTE), post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and VTE related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location). Number of patients with particular clinical outcome are reported.


Enrollment: 9
Study Start Date: June 2009
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dabigatran etexilate
open label; patient to receive dabigatran etexilate BID for three days
Drug: dabigatran etexilate
2.14 mg/kg BID to a max 150 mg BID

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. males or females 12 to less than 18 years of age
  2. objective diagnosis of primary VTE
  3. completion of planned treatment course with LMWH or OAC for primary VTE
  4. written informed consent by parent (legal guardian) and patient assent

Exclusion criteria:

  1. weight less than 32 kg
  2. conditions associated with increased risk of bleeding
  3. severe renal dysfunction or requirement for dialysis
  4. active infective endocarditis
  5. hepatic disease
  6. pregnant females or females not using medically accepted contraceptive method
  7. anemia or thrombocytopenia
  8. use of prohibited or restricted drug within previous week
  9. received investigational drug within past 30 days
  10. unreliable patients or patients who have any condition that would not allow safe participation in study
  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: NCT00844415

Locations
Canada, Alberta
1160.88.00002 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
Canada, Ontario
1160.88.00001 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00844415     History of Changes
Other Study ID Numbers: 1160.88
Study First Received: February 13, 2009
Results First Received: February 13, 2013
Last Updated: June 3, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014