Clinical trial NCT02223260: Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 8
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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 and adults and to confirm dabigatran etexilate dosing algorithm for children aged less than 1 year.

Detailed description: Purpose:

Eligibility criteria: 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

Primary outcomes:
measure: Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate
timeFrame: 2 hours (h) and 12h after drug administration on day 1
measure: Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
timeFrame: 2 h, and 12 h after dosing on day 1
measure: Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
timeFrame: 2 h, and 12 h after dosing on day 1
measure: Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
timeFrame: 2 h, and 12 h after dosing on day 1
measure: Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
timeFrame: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
measure: Central Measurement: The Mean ECT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
timeFrame: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
measure: Central Measurement: The Mean of dTT Ratio at 2h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
timeFrame: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
Secondary outcomes:
measure: PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters APTT Values.
timeFrame: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
measure: PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters ECT Values.
timeFrame: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
measure: PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters dTT Values.
timeFrame: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
measure: Incidence of All Bleeding Events (Major, CRNM and Minor) During the Treatment Period.
timeFrame: Within two days after the administration of trial medication, up to 3 days
measure: Incidence of All AEs During the Treatment Period
timeFrame: Within two days after the administration of trial medication, up to 3 days
measure: Global Assessment of Acceptability and Tolerability of Study Medication
timeFrame: Day 1 (immediately after dosing)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: 1160.105.10002 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 1160.105.10003 Boehringer Ingelheim Investigational Site
state: Quebec
city: Paris
country: France
facility: 1160.105.33001 Boehringer Ingelheim Investigational Site
city: Kazan
country: Russian Federation
facility: 1160.105.70005 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: