Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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1 February 2020 |
Main ID: |
EUCTR2014-000583-18-FI |
Date of registration:
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28/05/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Safety of dabigatran etexilate in blood clot prevention in children
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Scientific title:
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Open label, single arm safety prospective cohort study of dabigatran etexilate for secondary prevention of venous thromboembolism in children from 0 to less than 18 years |
Date of first enrolment:
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13/06/2014 |
Target sample size:
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100 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000583-18 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Austria
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Belgium
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Brazil
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Bulgaria
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Canada
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Colombia
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Czech Republic
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Denmark
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Finland
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France
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Germany
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Greece
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Hungary
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Israel
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Italy
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Lithuania
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Mexico
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Norway
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Poland
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Russian Federation
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Slovakia
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Spain
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Sweden
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Switzerland
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Taiwan
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Thailand
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Turkey
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Ukraine
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United States
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Contacts
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Name:
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QRPE pSC CT Information Disclosure
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Address:
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Binger Strasse 173
55216
Ingelheim am Rhein
Germany |
Telephone:
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+18002430127 |
Email:
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clintriage.rdg@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim Pharma GmbH & Co. KG |
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Name:
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QRPE pSC CT Information Disclosure
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Address:
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Binger Strasse 173
55216
Ingelheim am Rhein
Germany |
Telephone:
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+18002430127 |
Email:
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clintriage.rdg@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim Pharma GmbH & Co. KG |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Male or female subjects 0 to less than 18 years of age at the time of informed consent / assent
- Previously documented objective diagnosis of VTE (e.g. DVT, PE, central line thrombosis, sinus vein thrombosis), followed by completed course of initial VTE treatment for at least 3 months (in case of VKA - intended INR between 2 and 3) or completed study treatment (i.e. reached Visit 8) in the 1160.106 trial. Patients, who during the treatment phase of 1160.106 trial were switched from dabigatran etexilate to SOC arm for any reason, are not eligible for this study
- Presence of an unresolved clinical risk factor requiring further anticoagulation for secondary VTE prevention (e.g. central venous line, underlying disease, thrombophilia, etc.)
- Written informed consent form (ICF) provided by the patient's parent or legal guardian and assent provided by the patient (if applicable) at the time of ICF signature according to local regulations. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: - Conditions associated with an increased risk of bleeding
- Renal dysfunction (eGFR < 50 mL/min/1.73m2 for all patients using the Schwartz formula) or requirement for dialysis
- Active infective endocarditis
- Subjects with a a heart valve prosthesis requiring anticoagulation
- Hepatic disease: Active liver disease, including known active hepatitis A, B or C or Persistent alanine aminotransferase (ALT) or aspartate transaminase (AST) or alkaline phosphatase (AP) > 3 × upper limit of normal (ULN) within 3 months of screening. Transient increases of these parameters are acceptable, if retesting demonstrates results within these limits
- Pregnant or breast feeding females. Females who have reached menarche and are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study and / or do not agree to adhere to pregnancy testing required by this protocol
- Patients in age group 0 to < 2 years with gestational age at birth < 37 weeks or with body weight lower than the 3rd percentile (according to the WHO Child growth standards)
- Anemia (hemoglobin < 80g/L) or thrombocytopenia (platelet count < 80 x 109/L) at screening. Transfusions during the screening period are allowed, provided that a satisfactory hemoglobin or platelet level is attained prior to visit 2
- Patients who have taken restricted medication prior to first dose of study medication
- Patients who have received an investigational drug in the past 30 days prior to screening, except patients who have completed the treatment period (up to Visit 8) in 1160.106 trial
- Patients who are allergic/sensitive to any component of the study medication including solvent
- Patients or parents/legal guardians considered unreliable to participate in the trial per investigator judgment or any condition which would present a safety hazard to the patient based on investigator judgment
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Secondary prevention of venous thromboembolism
MedDRA version: 20.0
Level: LLT
Classification code 10049909
Term: Venous thromboembolism prophylaxis
System Organ Class: 100000004865
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Intervention(s)
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Product Name: dabigatran etexilate, 50 mg Product Code: BIBR 1048 MS Pharmaceutical Form: Capsule, hard INN or Proposed INN: DABIGATRAN ETEXILATE Current Sponsor code: BIBR 1048 MS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
Trade Name: Pradaxa Product Name: dabigatran etexilate, 75 mg Product Code: BIBR 1048 MS Pharmaceutical Form: Capsule, hard INN or Proposed INN: DABIGATRAN ETEXILATE Current Sponsor code: BIBR 1048 MS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75-
Trade Name: Pradaxa Product Name: dabigatran etexilate, 110 mg Product Code: BIBR 1048 MS Pharmaceutical Form: Capsule, hard INN or Proposed INN: DABIGATRAN ETEXILATE Current Sponsor code: BIBR 1048 MS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 110-
Product Name: dabigatran etexilate, 20 mg Product Code: BIBR 1048 MS Pharmaceutical Form: Granules in sachet INN or Proposed INN: DABIGATRAN ETEXILATE Current Sponsor code: BIBR 1048 MS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20-
Product Name: dabigatran etexilate, 30 mg Product Code: BIBR 1048 MS Pharmaceuti
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Primary Outcome(s)
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Primary end point(s): 1: Recurrence of venous thromboembolism (VTE) 2: Major and minor (including clinically relevant non-major (CRNM)) bleeding events 3: Mortality overall and related to thrombotic or thromboembolic events
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Timepoint(s) of evaluation of this end point: 1: 6 and 12 months 2: 6 and 12 months 3: 6 and 12 months
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Main Objective: To assess the safety of dabigatran etexilate used for secondary prevention of venous thromboembolism in children from 0 to less than 18 years of age.
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Secondary Objective: Not applicable
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1: 6 and 12 months
2: at Visit 3 (after at least six consecutive dabigatran etexilate doses) and after at least 3 days following any dabigatran etexilate dose adjustment
3: at Visit 3 (after at least six consecutive dabigatran etexilate doses) and after at least 3 days following any dabigatran etexilate dose adjustment
4: 12 months
5: at Visit 3 (after at least six consecutive dabigatran etexilate doses) and after at least 3 days following any dabigatran etexilate dose adjustment
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Secondary end point(s): 1: Occurrence of post-thrombotic syndrome (PTS)
2: Central measurement of aPTT (Activated partial thromboplastin time)
3: Central measurement of ECT (Ecarin clotting time )
4: Number of dabigatran etexilate dose adjustments during treatment period
5: Central measurement of dTT (Anti-Factor IIa activity)
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Secondary ID(s)
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1160.108
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2014-000583-18-ES
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Source(s) of Monetary Support
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Boehringer Ingelheim Finland Ky
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Ethics review
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Status: Approved
Approval date: 12/06/2014
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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