Safety and Tolerability of Dabigatran Etexilate in Adolescents

Venous Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844415
• Other study ID #: 1160.88
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2009
• Last updated: June 3, 2014
• Start date: June 2009

Study information

• Verified date: December 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• dabigatran etexilate
2.14 mg/kg BID to a max 150 mg BID

Locations

Country	Name	City	State
Canada	1160.88.00002 Boehringer Ingelheim Investigational Site	Edmonton	Alberta
Canada	1160.88.00001 Boehringer Ingelheim Investigational Site	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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)	No
Primary	Plasma Concentration of Free Dabigatran	Plasma concentration of free dabigatran measured at 72 hours after first dose	3 days	No
Primary	Plasma Concentration of Total Dabigatran	Plasma concentration of total dabigatran measured at 72 hours after first dose	Day 3	No
Primary	Thrombin Time (TT) Centrally Measured	Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.	Day 3	No
Primary	TT Locally Measured	Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.	Day 3	No
Secondary	Activated Partial Thromboplastin Time (aPTT) Centrally Measured	Measurement of aPTT was performed locally and centrally using validated assays.	Day 3	No
Secondary	aPTT Locally Measured	Measurement of aPTT was performed locally and centrally using validated assays.	Day 3	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Link