Venous ThromboembolismPhase 2NCT00844415
Safety and Tolerability of Dabigatran Etexilate in Adolescents
A Phase 2 study testing dabigatran etexilate in people with Venous Thromboembolism, run by Boehringer Ingelheim at 2 sites in Canada.
Trial summary
To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- dabigatran etexilate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jun 2009to 1 Feb 2012
- Phase
- Phase 2
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- males or females 12 to less than 18 years of age
- objective diagnosis of primary VTE
- completion of planned treatment course with LMWH or OAC for primary VTE
- written informed consent by parent (legal guardian) and patient assent
Who cannot join
- weight less than 32 kg
- conditions associated with increased risk of bleeding
- severe renal dysfunction or requirement for dialysis
- active infective endocarditis
- hepatic disease
- pregnant females or females not using medically accepted contraceptive method
Show all 10Show fewer
- anemia or thrombocytopenia
- use of prohibited or restricted drug within previous week
- received investigational drug within past 30 days
- unreliable patients or patients who have any condition that would not allow safe participation in study
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
1160.88.00002 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1160.88.00001 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
About this study
Official title: Open-label Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given for 3 Days at the End of Standard Anticoagulant Therapy in Children Aged 12 Years to Less Than 18 Years
To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.
- 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
2.14 mg/kg BID to a max 150 mg BID
| Study group | Role | What they receive |
|---|---|---|
| dabigatran etexilate | Experimental | open label; patient to receive dabigatran etexilate BID for three days Receives: Drug: dabigatran etexilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Bleeding Events (Major and Minor)
Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria:
Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds.
Measured: From Screening until 30 days after first drug administration (end of trial visit)
Number of Patients With Adverse Events
Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period. Events were considered "on-treatment" if occurring within 72 hours after last drug administration.
Measured: From Screening until 30 days after first drug administration (end of trial visit)
Plasma Concentration of Free Dabigatran
Plasma concentration of free dabigatran measured at 72 hours after first dose
Measured: 3 days
Plasma Concentration of Total Dabigatran
Plasma concentration of total dabigatran measured at 72 hours after first dose
Measured: Day 3
Thrombin Time (TT) Centrally Measured
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
Measured: Day 3
TT Locally Measured
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
Measured: Day 3
Secondary outcomes (5)
Activated Partial Thromboplastin Time (aPTT) Centrally Measured
Measurement of aPTT was performed locally and centrally using validated assays.
Measured: Day 3
aPTT Locally Measured
Measurement of aPTT was performed locally and centrally using validated assays.
Measured: Day 3
Ecarin Clotting Time (ECT)
Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT.
Measured: Day 3
Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs
Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.
Measured: Baseline and 3 days
Occurences of Clinical Outcome
Occurrences of clinical outcomes including recurrent venous thrombolic event (VTE), post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and VTE related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location). Number of patients with particular clinical outcome are reported.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study start1 Jun 2009
- Primary completion1 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT00844415
- Sponsor's protocol ID
- 1160.88
- Status last verified
- Jan 2025
- First submitted
- 13 Feb 2009
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Publications
Halton JM, Lehr T, Cronin L, Lobmeyer MT, Haertter S, Belletrutti M, Mitchell LG. Safety, tolerability and clinical pharmacology of dabigatran etexilate in adolescents. An open-label phase IIa study. Thromb Haemost. 2016 Aug 30;116(3):461-71. doi: 10.1160/TH15-04-0275. Epub 2016 Jun 30.
PubMed 27357738