Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age

Venous Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223260
• Other study ID #: 1160.105
• Secondary ID: 2014-001259-22
• Status: Completed
• Phase: Phase 2
• First received: August 21, 2014
• Last updated: February 23, 2016
• Start date: September 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices AgencyCanada: Health CanadaFrance: Agence Nationale de Sécurité du Médicament et des produits de santéRussia: Pharmacological Committee, Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Purpose:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• dabigatran
Experimental dose chosen based on age and weight

Locations

Country	Name	City	State
Austria	1160.105.43001 Boehringer Ingelheim Investigational Site	Wien
Canada	1160.105.10003 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1160.105.10002 Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	1160.105.10001 Boehringer Ingelheim Investigational Site	Toronto	Ontario
France	1160.105.33001 Boehringer Ingelheim Investigational Site	Paris
Russian Federation	1160.105.70005 Boehringer Ingelheim Investigational Site	Kazan
Russian Federation	1160.105.70004 Boehringer Ingelheim Investigational Site	Kemerovo
Russian Federation	1160.105.70001 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1160.105.70002 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1160.105.70003 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1160.105.70006 Boehringer Ingelheim Investigational Site	Yekaterinburg

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Canada,  France,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of total dabigatran, 2h and 12 h (+/-2h) post administration of dabigatran etexilate		day 1	No
Primary	Central measurement of activated Partial Thromboplastin Time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate.		day 1	No
Primary	Central measurement of Ecarin Clotting Time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate.		day 1	No
Primary	Central measurement of AntiFactor IIa activity (diluted thrombin time) at 2 h and 12h (+/-2h) post administration of dabigatran etexilate.		day 1	No
Secondary	PK-PD relationship		day 1	No
Secondary	Incidence of all bleeding events (major and minor) during the treatment period (including residual effect period (REP))		up to day 3	Yes
Secondary	Incidence of all adverse events during the treatment period (including REP)		up tp day 3	No
Secondary	Global assessment of acceptability and tolerability of the study medication		day 1	No