To provide single dose PK/PD dataTo investigate tolerability and safety of dabigatran etexilate solution in children1 to
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- incidence of all bleeding events (major and minor);
- incidence of all adverse events.
Secondary outcome
- changes in laboratory and clinical parameters such as liver enzymes, ECG and
physical examination;
- occurrences of clinical outcomes including recurrent thrombosis, post
thrombotic syndrome (PTS), pulmonary emboli (PE), and total and venous
thrombolic event (VTE) related mortality objectively assessed for example by
ultrasound, venography or CT scan;
- global assessment of tolerability to studymedication.
Background summary
Single dose open-label PK/PD, safety and tolerability 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 and 1 year to less than 2
years.
Study objective
To provide single dose PK/PD data
To investigate tolerability and safety of dabigatran etexilate solution in
children
1 to <12 years of age
Study design
This is an open-label, multi-centre, non-randomised, uncontrolled, single dose,
single
arm study.
Intervention
After completion of standard anticoagulation therapy the studymedication will
be prescribed: dabigatran etexilate. The patient will visit the study site 3
times. During every visit a bloodsample is withdrawn and during visit 2 a total
of 6 bloodsamples are withdrawn. During visit 1 and 3 a pregnancy test is
performed (if applicable). During the first visit an ECG is performed. To avoid
pregnancy, girls who have reached menarche need to use a medically accepted
contraceptive method which is prescribed in the protocol.
Study burden and risks
After completion of standard anticoagulation therapy the studymedication will
be prescribed: dabigatran etexilate. The patient will visit the study site 3
times. During every visit a bloodsample is withdrawn and during visit 2 a total
of 6 bloodsamples are withdrawn. During visit 1 and 3 a pregnancy test is
performed (if applicable). During the first visit an ECG is performed. To avoid
pregnancy, girls who have reached menarche need to use a medically accepted
contraceptive method which is prescribed in the protocol.
Comeniusstraat 6
ALKMAAR 1817 MS
NL
Comeniusstraat 6
ALKMAAR 1817 MS
NL
Listed location countries
Age
Inclusion criteria
Stable pediatric patients objectively diagnosed with a venous thrombotic event
Exclusion criteria
- weight less than 9 kg;
- previous history of cerebral venous thromboembolism;
- conditions associated with a increased risk of bleeding;
- severe renal dysfunction;
- active infective endocarditis;
- hepatic disease.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-013618-29-NL |
| Other | na |
| CCMO | NL41119.000.12 |