Clinical trial NCT00844415: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-02-16
Enrollment: 9
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of Patients With Bleeding Events (Major and Minor)
timeFrame: From Screening until 30 days after first drug administration (end of trial visit)
measure: Number of Patients With Adverse Events
timeFrame: From Screening until 30 days after first drug administration (end of trial visit)
measure: Plasma Concentration of Free Dabigatran
timeFrame: 3 days
measure: Plasma Concentration of Total Dabigatran
timeFrame: Day 3
measure: Thrombin Time (TT) Centrally Measured
timeFrame: Day 3
measure: TT Locally Measured
timeFrame: Day 3
Secondary outcomes:
measure: Activated Partial Thromboplastin Time (aPTT) Centrally Measured
timeFrame: Day 3
measure: aPTT Locally Measured
timeFrame: Day 3
measure: Ecarin Clotting Time (ECT)
timeFrame: Day 3
measure: Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs
timeFrame: Baseline and 3 days
measure: Occurences of Clinical Outcome
timeFrame: 3 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: 1160.88.00002 Boehringer Ingelheim Investigational Site
state: Alberta
city: Ottawa
country: Canada
facility: 1160.88.00001 Boehringer Ingelheim Investigational Site
state: Ontario
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
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.