Safety and Tolerability of Dabigatran Etexilate in Adolescents

Boehringer Ingelheim9 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Venous Thromboembolism

Interventions

dabigatran etexilateDRUG

2.14 mg/kg BID to a max 150 mg BID

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (2)

1160.88.00002 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

1160.88.00001 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 3 days

Plasma Concentration of Total Dabigatran

Plasma concentration of total dabigatran measured at 72 hours after first dose

Time frame: Day 3

Thrombin Time (TT) Centrally Measured

Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.

Time frame: Day 3

TT Locally Measured

Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.

Data from ClinicalTrials.gov

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Secondary Outcomes

Activated Partial Thromboplastin Time (aPTT) Centrally Measured

Measurement of aPTT was performed locally and centrally using validated assays.

Time frame: Day 3

aPTT Locally Measured

Measurement of aPTT was performed locally and centrally using validated assays.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 3 days