Status:
COMPLETED
Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE2
Brief Summary
The aim of the study is to investigate the safety and tolerability of dabigatran etexilate solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to older children an...
Detailed Description
Purpose:
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02223260
Start Date
September 1 2014
End Date
February 1 2016
Last Update
September 20 2016
Active Locations (4)
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1
1160.105.10002 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
2
1160.105.10003 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
3
1160.105.33001 Boehringer Ingelheim Investigational Site
Paris, France
4
1160.105.70005 Boehringer Ingelheim Investigational Site
Kazan', Russia