Back to resultsPharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age
Primary Purpose
Venous Thromboembolism
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dabigatran etexilate
Sponsored by
About this trial
This is an interventional treatment trial for Venous Thromboembolism
Eligibility Criteria
Inclusion criteria:
- males or females 1 to less than 2 years of age
- objective diagnosis of primary venous thromboembolism
- completion of planned treatment course with low molecular weight heparin or oral anticoagulant for primary venous thromboembolism
- written informed consent by parent (legal guardian) and patient assent (if applicable)
Exclusion criteria:
- weight less than 9 kg
- conditions associated with increased risk of bleeding
- patients who have any condition that would not allow safe participation in study Note: Further exclusion criteria apply
Sites / Locations
- 1160.145.00010 Boehringer Ingelheim Investigational Site
- 1160.145.00009 Boehringer Ingelheim Investigational Site
- 1160.145.00008 Boehringer Ingelheim Investigational Site
- 1160.145.00012 Boehringer Ingelheim Investigational Site
- 1160.145.00007 Boehringer Ingelheim Investigational Site
- 1160.145.0006 Boehringer Ingelheim Investigational Site
- 1160.145.00001 Boehringer Ingelheim Investigational Site
- 1160.145.00011 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dabigatran etexilate
Arm Description
single dose treatment with dabigatran oral solution
Outcomes
Primary Outcome Measures
Ecarin clotting time (ECT)
Factor IIa inhibition
Incidence of all bleeding events
Incidence of all adverse events
Plasma concentrations of total dabigatran
Plasma concentrations of free dabigatran
Plasma concentrations of BIBR 1048 BS (Base)
Plasma concentrations of BIBR 951 BS
Plasma concentrations of BIBR 1087 SE (Acid)
Activated prothrombin time (aPTT)
Secondary Outcome Measures
Global assessment of tolerability will be summarized across all patients in the treated set
Patient assessment of taste will be summarized across all patients in the treated set
Changes in laboratory and clinical parameters
Full Information
NCT ID
NCT01773174
First Posted
January 18, 2013
Last Updated
October 23, 2015
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT01773174
Brief Title
Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dabigatran etexilate
Arm Type
Experimental
Arm Description
single dose treatment with dabigatran oral solution
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate
Intervention Description
age & weight adjusted equivalent of adult dose
Primary Outcome Measure Information:
Title
Ecarin clotting time (ECT)
Time Frame
one day
Title
Factor IIa inhibition
Time Frame
one day
Title
Incidence of all bleeding events
Time Frame
30 days
Title
Incidence of all adverse events
Time Frame
30 days
Title
Plasma concentrations of total dabigatran
Time Frame
one day
Title
Plasma concentrations of free dabigatran
Time Frame
one day
Title
Plasma concentrations of BIBR 1048 BS (Base)
Time Frame
one day
Title
Plasma concentrations of BIBR 951 BS
Time Frame
one day
Title
Plasma concentrations of BIBR 1087 SE (Acid)
Time Frame
one day
Title
Activated prothrombin time (aPTT)
Time Frame
one day
Secondary Outcome Measure Information:
Title
Global assessment of tolerability will be summarized across all patients in the treated set
Time Frame
30 days
Title
Patient assessment of taste will be summarized across all patients in the treated set
Time Frame
one day
Title
Changes in laboratory and clinical parameters
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
males or females 1 to less than 2 years of age
objective diagnosis of primary venous thromboembolism
completion of planned treatment course with low molecular weight heparin or oral anticoagulant for primary venous thromboembolism
written informed consent by parent (legal guardian) and patient assent (if applicable)
Exclusion criteria:
weight less than 9 kg
conditions associated with increased risk of bleeding
patients who have any condition that would not allow safe participation in study Note: Further exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1160.145.00010 Boehringer Ingelheim Investigational Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
1160.145.00009 Boehringer Ingelheim Investigational Site
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
1160.145.00008 Boehringer Ingelheim Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
1160.145.00012 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
1160.145.00007 Boehringer Ingelheim Investigational Site
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
1160.145.0006 Boehringer Ingelheim Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
1160.145.00001 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1160.145.00011 Boehringer Ingelheim Investigational Site
City
Spokane
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age
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