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

Recruitment & Eligibility

Status: ot Recruiting

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 with INR and aPTT both within normal limits. End of planned treatment course is defined as the end of all need for anticoagulant therapy as per the standard of care at the investigational site. 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. All informed consent / assent forms should be consistent with ICH / GCP and Local Institutional Review Board (IRB) requirements and must be obtained prior to any study procedures being performed.
Are the trial subjects under 18? yes
Number of subjects for this age range: 33
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: a) Any hemorrhagic stroke b) Major surgery in the previous month c) Planned surgery or invasive procedure in the next 30 days d) History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra- articular bleeding e) Gastrointestinal haemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery) f) Any history of gastroduodenal ulcer disease g) Hemorrhagic disorder or bleeding diathesis h) Required concurrent treatment with another LMWH, UFH, oral anticoagulant or antiplatelet agent i) Fibrinolytic agents within 48 hours of study entry j) Uncontrolled hypertension on antihypertensive medication (systolic and/or diastolic above the upper limit of normal for age sustained over 24 h) 3) Severe renal dysfunction (eGFR < 80mL/min/1.73m2 using the Schwartz formula, refer to Appendix 10.1) or requirement for dialysis 4) Active infective endocarditis 5) Hepatic disease: a) INR >2.5 (>3.0 if on OAC) or an activated partial thromboplastin time (aPTT) >100 s or, b) Active liver disease, including known hepatitis A, B or C or, c) Persistent ALT, AST, Alk. Phos >2 x ULN 6)Females who have reached menarche with a positive pregnancy test or not using a medically accepted contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD); oral, implantable or injectable contraceptives and estrogen patch; double barrier method (spermacide + diaphragm); or abstinence at the discretion of the investigator. 7) Anaemia (haemoglobin <80g/L) or thrombocytopenia (platelet count <10080 x109/L). Transfusions are allowed to attain satisfactory levels. 8) Patients who have taken any prohibited / restricted medication / treatment (other than those used for planned VTE treatment) within one week of first dose of study medication. For trial restrictions please see Section 4.2.2. 9) Patients who have received an investigational drug in the past 30 days 10) Patients who are allergic / sensitive to any component of the study medication and/or solvent 11) Patients considered unreliable by the investigator concerning the requirements for followup during the study and / or compliance with study drug administration, or has any condition which in the opinion of the investigator, would not allow safe participation in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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