Tolerability , PK/PD and safety of dabigatran etexilate oral liquid formulation in children < 1 year of age

• Conditions: venous thrombotic event; MedDRA version: 17.1Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-001259-22-AT
• Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-02
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To investigate tolerability and safety of dabigatran etexilate solution in newborns and infants aged less than 1 year;Main Objective: To confirm dabigatran etexilate dosing algorithm for newborns and infants aged less than 1 year and to assess comparable PK/PD relationship to older children and adults;Primary end point(s): 1: Plasma concentrations of total dabigatran, 2h and 12 h (+/-2h) post administration of dabigatran etexilate<br><br>2: Central measurement of activated Partial Thromboplastin Time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate.<br><br>3: Central measurement of AntiFactor IIa activity (diluted thrombin time) at 2 h and 12h (+/-2h) post administration of dabigatran etexilate.<br><br>4: Central measurement of Ecarin Clotting Time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate.<br><br>;Timepoint(s) of evaluation of this end point: 1: day 1<br><br>2: day 1<br><br>3: day 1<br><br>4: day 1

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1: PK-PD relationship<br><br>2: Incidence of all bleeding events (major and minor) during the treatment period (including residual effect period (REP))<br><br>3: Incidence of all adverse events during the treatment period (including REP)<br><br>4: Global assessment of acceptability and tolerability of the study medication<br>;Timepoint(s) of evaluation of this end point: 1: day 1<br><br>2: up to day 3<br><br>3: up tp day 3<br><br>4: day 1<br>