EUCTR2014-001259-22-ITActive, not recruitingNot Applicable
open-label, single dose, tolerability, Pharmacokinetic/Pharmacodynamics and safety study of dabigatran etexilate given at the end of standard anticoagulant therapy in children aged less than 1 year old
Boehringer Ingelheim Italia S.p.A.0 sites12 target enrollmentStarted: August 4, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Neonates and infants with aged < 12 months at Visit 1
- •- Objective diagnosis of VTE
- •- End of planned treatment course with anticoagulant therapy as per standard of care at the investigator site.
- •- Written informed consent provided by the patient's parent(s) (or legal guardian) according to local regulations at Visit 1.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 8
- •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
- •- Weight less than 3 kg at Visit 1
- •- Conditions associated with an increased risk of bleeding
- •- renal dysfunction
- •- hepatic disease
- •- Anemia or thrombocytopenia at screening
Investigators
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