Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 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 Children Aged 1 Year to Less Than 2 Years in Conjunction With Study 1160.89

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01773174
• Other study ID #: 1160.145
• Status: Withdrawn
• Phase: Phase 2
• First received: January 18, 2013
• Last updated: October 23, 2015
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 2 Years

Eligibility

Inclusion criteria:

1. males or females 1 to less than 2 years of age

2. objective diagnosis of primary venous thromboembolism

3. completion of planned treatment course with low molecular weight heparin or oral anticoagulant for primary venous thromboembolism

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, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• dabigatran etexilate
age & weight adjusted equivalent of adult dose

Locations

Country	Name	City	State
United States	1160.145.00008 Boehringer Ingelheim Investigational Site	Boston	Massachusetts
United States	1160.145.00001 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	1160.145.00009 Boehringer Ingelheim Investigational Site	Louisville	Kentucky
United States	1160.145.00007 Boehringer Ingelheim Investigational Site	Newark	New Jersey
United States	1160.145.0006 Boehringer Ingelheim Investigational Site	Pittsburgh	Pennsylvania
United States	1160.145.00010 Boehringer Ingelheim Investigational Site	Sacramento	California
United States	1160.145.00011 Boehringer Ingelheim Investigational Site	Spokane	Washington
United States	1160.145.00012 Boehringer Ingelheim Investigational Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
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
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		one day	No
Secondary	Changes in laboratory and clinical parameters		30 days	No