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Safety and Tolerability of Dabigatran Etexilate in Adolescents

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
dabigatran etexilate
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1160.88.00002 Boehringer Ingelheim Investigational Site
  • 1160.88.00001 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dabigatran etexilate

Arm Description

open label; patient to receive dabigatran etexilate BID for three days

Outcomes

Primary Outcome Measures

Number of Patients With Bleeding Events (Major and Minor)
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
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
Plasma concentration of free dabigatran measured at 72 hours after first dose
Plasma Concentration of Total Dabigatran
Plasma concentration of total dabigatran measured at 72 hours after first dose
Thrombin Time (TT) Centrally Measured
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
TT Locally Measured
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.

Secondary Outcome Measures

Activated Partial Thromboplastin Time (aPTT) Centrally Measured
Measurement of aPTT was performed locally and centrally using validated assays.
aPTT Locally Measured
Measurement of aPTT was performed locally and centrally using validated assays.
Ecarin Clotting Time (ECT)
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
Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.
Occurences of Clinical Outcome
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.

Full Information

First Posted
February 13, 2009
Last Updated
June 3, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00844415
Brief Title
Safety and Tolerability of Dabigatran Etexilate in Adolescents
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dabigatran etexilate
Arm Type
Experimental
Arm Description
open label; patient to receive dabigatran etexilate BID for three days
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate
Intervention Description
2.14 mg/kg BID to a max 150 mg BID
Primary Outcome Measure Information:
Title
Number of Patients With Bleeding Events (Major and Minor)
Description
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.
Time Frame
From Screening until 30 days after first drug administration (end of trial visit)
Title
Number of Patients With Adverse Events
Description
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.
Time Frame
From Screening until 30 days after first drug administration (end of trial visit)
Title
Plasma Concentration of Free Dabigatran
Description
Plasma concentration of free dabigatran measured at 72 hours after first dose
Time Frame
3 days
Title
Plasma Concentration of Total Dabigatran
Description
Plasma concentration of total dabigatran measured at 72 hours after first dose
Time Frame
Day 3
Title
Thrombin Time (TT) Centrally Measured
Description
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
Time Frame
Day 3
Title
TT Locally Measured
Description
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Activated Partial Thromboplastin Time (aPTT) Centrally Measured
Description
Measurement of aPTT was performed locally and centrally using validated assays.
Time Frame
Day 3
Title
aPTT Locally Measured
Description
Measurement of aPTT was performed locally and centrally using validated assays.
Time Frame
Day 3
Title
Ecarin Clotting Time (ECT)
Description
Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT.
Time Frame
Day 3
Title
Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs
Description
Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.
Time Frame
Baseline and 3 days
Title
Occurences of Clinical Outcome
Description
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.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: males or females 12 to less than 18 years of age objective diagnosis of primary VTE completion of planned treatment course with LMWH or OAC for primary VTE written informed consent by parent (legal guardian) and patient assent Exclusion criteria: weight less than 32 kg conditions associated with increased risk of bleeding severe renal dysfunction or requirement for dialysis active infective endocarditis hepatic disease pregnant females or females not using medically accepted contraceptive method anemia or thrombocytopenia use of prohibited or restricted drug within previous week received investigational drug within past 30 days unreliable patients or patients who have any condition that would not allow safe participation in study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1160.88.00002 Boehringer Ingelheim Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1160.88.00001 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27357738
Citation
Halton JM, Lehr T, Cronin L, Lobmeyer MT, Haertter S, Belletrutti M, Mitchell LG. Safety, tolerability and clinical pharmacology of dabigatran etexilate in adolescents. An open-label phase IIa study. Thromb Haemost. 2016 Aug 30;116(3):461-71. doi: 10.1160/TH15-04-0275. Epub 2016 Jun 30.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.88_U12-3378-01-DS.pdf
Description
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Safety and Tolerability of Dabigatran Etexilate in Adolescents

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