Safety of dabigatran etexilate in blood clot prevention in children

• Register: EUCTR
• Last refreshed on: 1 February 2020
• Main ID: EUCTR2014-000583-18-FI
• Date of registration: 28/05/2014
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim Finland Ky
• Public title: Safety of dabigatran etexilate in blood clot prevention in children
• Scientific title: 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: 13/06/2014
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000583-18
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Mexico, Norway, Poland, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United States

Contacts

• Name: QRPE pSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

• Name: QRPE pSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Secondary prevention of venous thromboembolism
MedDRA version: 20.0 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 100000004865

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

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

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 1: 6 and 12 months

2: 6 and 12 months

3: 6 and 12 months

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.

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

Secondary Objective: Not applicable

Secondary Outcome(s)

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

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)

Secondary ID(s)

1160.108

2014-000583-18-ES

Source(s) of Monetary Support

Boehringer Ingelheim Finland Ky

Ethics review

Status: Approved
Approval date: 12/06/2014
Contact: