Venous ThromboembolismPhase 2NCT01773174
Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age
A Phase 2 study testing dabigatran etexilate in people with Venous Thromboembolism, run by Boehringer Ingelheim at 8 sites in United States.
Trial summary
Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group Read more about this study
- Who is it for?
- Ages 1 year to 2 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- dabigatran etexilate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
1160.145.00008 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
1160.145.00001 Boehringer Ingelheim Investigational Site
Houston, Texas
1160.145.00009 Boehringer Ingelheim Investigational Site
Louisville, Kentucky
1160.145.00007 Boehringer Ingelheim Investigational Site
Newark, New Jersey
1160.145.0006 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1160.145.00010 Boehringer Ingelheim Investigational Site
Sacramento, California
1160.145.00011 Boehringer Ingelheim Investigational Site
Spokane, Washington
1160.145.00012 Boehringer Ingelheim Investigational Site
St Louis, Missouri
About this study
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 will assess PK/PD parameters and safety and tolerability of the study medication in this age group
- Conditions
- Venous Thromboembolism
- Being tested
- dabigatran etexilate
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dabigatran etexilateDrug
age \& weight adjusted equivalent of adult dose
| Study group | Role | What they receive |
|---|---|---|
| dabigatran etexilate | Experimental | single dose treatment with dabigatran oral solution Receives: Drug: dabigatran etexilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ecarin clotting time (ECT)
Measured: one day
Factor IIa inhibition
Measured: one day
Incidence of all bleeding events
Measured: 30 days
Incidence of all adverse events
Measured: 30 days
Plasma concentrations of total dabigatran
Measured: one day
Plasma concentrations of free dabigatran
Measured: one day
Plasma concentrations of BIBR 1048 BS (Base)
Measured: one day
Plasma concentrations of BIBR 951 BS
Measured: one day
Plasma concentrations of BIBR 1087 SE (Acid)
Measured: one day
Activated prothrombin time (aPTT)
Measured: one day
Secondary outcomes (3)
Global assessment of tolerability will be summarized across all patients in the treated set
Measured: 30 days
Patient assessment of taste will be summarized across all patients in the treated set
Measured: one day
Changes in laboratory and clinical parameters
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773174
- Sponsor's protocol ID
- 1160.145
- Status last verified
- Oct 2015
- First submitted
- 18 Jan 2013
- Last updated
- 26 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01773174
- Acronym / sponsor ID
- 1160.145
- Conditions
- Venous Thromboembolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dabigatran etexilate | Experimental | Drug: dabigatran etexilatesingle dose treatment with dabigatran oral solution |
Who may qualify
- Ages
- 1 year to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dabigatran etexilateage \& weight adjusted equivalent of adult dose | Drug | dabigatran etexilate |
Primary outcome
Ecarin clotting time (ECT)
Time frame: one day
Factor IIa inhibition
Time frame: one day
Incidence of all bleeding events
Time frame: 30 days
Incidence of all adverse events
Time frame: 30 days
Plasma concentrations of total dabigatran
Time frame: one day
Plasma concentrations of free dabigatran
Time frame: one day
Plasma concentrations of BIBR 1048 BS (Base)
Time frame: one day
Plasma concentrations of BIBR 951 BS
Time frame: one day
Plasma concentrations of BIBR 1087 SE (Acid)
Time frame: one day
Activated prothrombin time (aPTT)
Time frame: one day
3 secondary outcomes
Global assessment of tolerability will be summarized across all patients in the treated set
Time frame: 30 days
Patient assessment of taste will be summarized across all patients in the treated set
Time frame: one day
Changes in laboratory and clinical parameters
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
Related trials for Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dabigatran etexilate in people with Venous Thromboembolism, run by Boehringer Ingelheim at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ecarin clotting time (ECT) (time frame: one day). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2015.