Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age

Venous Thromboembolism Clinical Trial

Official title:

Single Dose Open-label PK/PD, Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given at the End of Standard Anticoagulant Therapy in Successive Groups of Children Aged 2 Years to Less Than 12 Years Followed by 1 Year to Less Than 2 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083732
• Other study ID #: 1160.89
• Secondary ID: 2009-013618-29
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2010
• Last updated: February 23, 2016
• Start date: March 2010
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Medicines and Medical Devices AgencyBelgium: Federal Agency for Medicinal and Health ProductsCanada: Health CanadaItaly: National Institute of HealthLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthNetherlands: Central Committee Research Involving Human SubjectsNorway: Norwegian Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthSpain: Spanish Agency of MedicinesSwitzerland: SwissmedicThailand: Food and Drug AdministrationUkraine: State Pharmacological Center - Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data

Description:

Purpose:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 11 Years

Eligibility

Inclusion criteria:

1. males or females 1 to less than 12 years of age

2. objective diagnosis of primary VTE

3. completion of planned treatment course with LMWH or OAC for primary VTE

4. written informed consent by parent (legal guardian) and patient assent (if applicable)

Exclusion criteria:

1. weight less than 9 kg

2. conditions associated with increased risk of bleeding

3. patients who have any condition that would not allow safe participation in study Note: Further exclusion criteria apply

Study Design

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

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

Locations

Country	Name	City	State
Austria	1160.89.43001 Boehringer Ingelheim Investigational Site	Wien
Belgium	1160.89.32003 Boehringer Ingelheim Investigational Site	Brussel
Canada	1160.89.00002 Boehringer Ingelheim Investigational Site	Edmonton	Alberta
Canada	1160.89.00001 Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	1160.89.00005 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Italy	1160.89.39001 Boehringer Ingelheim Investigational Site	Roma
Latvia	1160.89.37101 Boehringer Ingelheim Investigational Site	Riga
Lithuania	1160.89.37001 Boehringer Ingelheim Investigational Site	Vilnius
Netherlands	1160.89.31003 Boehringer Ingelheim Investigational Site	Nijmegen
Netherlands	1160.89.31004 Boehringer Ingelheim Investigational Site	Utrecht
Norway	1160.89.47001 Boehringer Ingelheim Investigational Site	Bergen
Russian Federation	1160.89.70005 Boehringer Ingelheim Investigational Site	Kazan
Russian Federation	1160.89.70004 Boehringer Ingelheim Investigational Site	Kemerovo
Russian Federation	1160.89.70001 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1160.89.70002 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1160.89.70003 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1160.89.70006 Boehringer Ingelheim Investigational Site	Yekaterinburg
Spain	1160.89.34001 Boehringer Ingelheim Investigational Site	Madrid
Spain	1160.89.34002 Boehringer Ingelheim Investigational Site	Madrid
Switzerland	1160.89.41001 Boehringer Ingelheim Investigational Site	Zürich
Thailand	1160.89.66001 Boehringer Ingelheim Investigational Site	Bangkok
Thailand	1160.89.66002 Boehringer Ingelheim Investigational Site	Bangkok
Thailand	1160.89.66003 Boehringer Ingelheim Investigational Site	Khon Kaen
Ukraine	1160.89.38001 Boehringer Ingelheim Investigational Site	Dnipropetrovsk
Ukraine	1160.89.38003 Boehringer Ingelheim Investigational Site	Vinnytsya
Ukraine	1160.89.38004 Boehringer Ingelheim Investigational Site	Zaporizhzhya
Ukraine	1160.89.38005 Boehringer Ingelheim Investigational Site	Zaporizhzhya

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Italy,  Latvia,  Lithuania,  Netherlands,  Norway,  Russian Federation,  Spain,  Switzerland,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of total dabigatran		one day	No
Primary	Plasma concentrations of free dabigatran		one day	No
Primary	Plasma concentrations of BIBR 1048 BS (Base)		one day	No
Primary	Plasma concentrations of BIBR 951 BS		one day	No
Primary	Plasma concentrations of BIBR 1087 SE (Acid)		one day	No
Primary	Activated prothrombin time (aPTT)		one day	No
Primary	Ecarin clotting time (ECT)		one day	No
Primary	Factor IIa inhibition		one day	No
Primary	Incidence of all bleeding events		30 days	No
Primary	Incidence of all adverse events		30 days	No
Secondary	Global assessment of tolerability will be summarized across all patients in the treated set		30 days	No
Secondary	Patient assessment of taste will be summarized across all patients in the treated set		30 days	No
Secondary	Changes in laboratory and clinical parameters		30 days	No