Safety and tolerability of dabigatran etexilate solution in children 1 to < 12 years of age

Phase 1

Conditions: Venous Thrombotic Event
MedDRA version: 19.0Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2009-013618-29-Outside-EU/EEA

Lead Sponsor: Boehringer Ingelheim (Canada) Ltd/Ltée

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 16

Inclusion Criteria

1) Male or female children 1 to < 12 years of age
2) Objective diagnosis of VTE
3) End of planned treatment course with low molecular weight heparin (LMWH) or oral
anticoagulant (OAC) for VTE.
4) Written informed consent provided by the patient’s parent (or legal guardian) and assent
provided by the patient (if applicable) at the time of ICF signature.
Are the trial subjects under 18? yes
Number of subjects for this age range: 16
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Weight less than 9 kg
2) Conditions associated with an increased risk of bleeding
3) 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This Phase IIa study will provide single dose pharmacokinetic and pharmacodynamic data<br>and assess tolerability and safety of dabigatran etexilate in successive groups of pediatric<br>patients aged 2 to <12 years followed by 1 to <2 years using an oral liquid formulation.;Secondary Objective: none;Primary end point(s): 1) Incidence of all bleeding events<br>2) Incidence of all adverse events<br>3) Pharmacodynamic parameters: Central measurement of aPTT, ECT, and Factor IIa (FIIa) inhibition<br>4) Pharmacokinetic parameters: plasma concentrations of total and free dabigatran, BIBR 1048 BS, BIBR 951BS, and BIBR 1087 SE<br>;Timepoint(s) of evaluation of this end point: Endpoints 1) & 2) measured during screening, treatment period and 30 day followup.<br>Endpoints 3) & 4) measured during screening (baseline) and treatment period.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Endpoint 1) is measured during screening, treatment period and 30 day followup.<br>Endpoint 2) is measured during treatment period;Secondary end point(s): 1) Changes in laboratory and clinical parameters such as liver enzymes and physical<br>examination<br>2) Global assessment of tolerability to study medication (including patient taste<br>assessment)