Safety and Tolerability of Dabigatran Etexilate in Adolescents

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

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

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Drug: dabigatran etexilate

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • 1160.88.00002 Boehringer Ingelheim Investigational Site
  • Ontario
    • Ottawa, Ontario, Canada
      • 1160.88.00001 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Screening until 30 days after first drug administration (end of trial visit)
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.	From Screening until 30 days after first drug administration (end of trial visit)
Plasma Concentration of Free Dabigatran	Plasma concentration of free dabigatran measured at 72 hours after first dose	3 days
Plasma Concentration of Total Dabigatran	Plasma concentration of total dabigatran measured at 72 hours after first dose	Day 3
Thrombin Time (TT) Centrally Measured	Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.	Day 3
TT Locally Measured	Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.	Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activated Partial Thromboplastin Time (aPTT) Centrally Measured	Measurement of aPTT was performed locally and centrally using validated assays.	Day 3
aPTT Locally Measured	Measurement of aPTT was performed locally and centrally using validated assays.	Day 3
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.	Day 3
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.	Baseline and 3 days
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.	3 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Investigators: Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2009
• Primary Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: February 13, 2009
• First Submitted That Met QC Criteria: February 13, 2009
• First Posted (Estimated): February 16, 2009

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Anticoagulants; Antithrombins; Serine Proteinase Inhibitors; Dabigatran
• Other Study ID Numbers: 1160.88

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency