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

Conditions: Venous Thrombotic Event
MedDRA version: 14.1Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2009-013618-29-LV

Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 16

Inclusion Criteria

1) Males or females 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 with INR and aPTT both within normal limits.
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) conditions associated with increased risk of bleeding
2) severe renal dysfunction or requirement for dialysis
3) active infective endocarditis
4) hepatic disease
5) anemia or thrombocytopenia
6) use of prohibited or restricted drug within previous week
7) pregnant females or females not using medically accepted contraceptive method
8) received investigational drug within past 30 days
9) unreliable patients or patients who have any condition that would not allow safe participation in study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study is exploratory in nature and will investigate safety and tolerability of an oral liquid formulation of dabigatran etexilate in pediatric patients 1 to < 12 years old treated for primary VTE. The study will also provide preliminary pharmacokinetic and pharmacodynamic data for this age group.;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 and local measurement of TT<br>4) Pharmacokinetic parameters: plasma concentrations of total and free dabigatran, BIBR 1048 BS, BIBR 951BS, and BIBR 1087 SE,;Timepoint(s) of evaluation of this end point: Endpoints 1) & 2) measured during screening, treatment period and 30 day follow-up.<br>Endpoints 3) & 4) measured during screening (baseline) and treatment period.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Change in laboratory and clinical parameters such as liver enzymes, ECG, and physical examination,<br>2) Occurrences of clinical outcomes including recurrent thrombosis, post thrombotic syndrome (PTS), pulmonary emboli (PE), and total and venous thrombotic event (VTE) related mortality,<br>3) Global assessment of tolerability to study medication (including patient taste assessment),<br>4) Pharmacodynamic parameters: local measurement of aPTT;Timepoint(s) of evaluation of this end point: Endpoints 1) to 3) measured during screening, treatment period and 30 day follow-up.<br>Endpoint 4) measured during screening (baseline) and treatment period.