Safety of Dabigatran Etexilate in Blood Clot Prevention in Children

NCT ID: NCT02197416

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-29
• Study Completion Date: 2019-11-19

Brief Summary

This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from 0 to less than 18 years of age will be eligible to participate.

Conditions

Venous Thromboembolism; Secondary Prevention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

dabigatran etexilate

Group Type: EXPERIMENTAL

dabigatran etexilate

Intervention Type: DRUG

Age and weight appropriate capsule dose (combination of 50 mg, 75 mg and 110 mg capsules) or pellets or oral liquid formulation

Interventions

dabigatran etexilate

Age and weight appropriate capsule dose (combination of 50 mg, 75 mg and 110 mg capsules) or pellets or oral liquid formulation

Intervention Type: DRUG

Eligibility 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, 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.

Exclusion Criteria

• Conditions associated with an increased risk of bleeding
• Renal dysfunction (eGFR < 50 mL/min/1.73m^2 using the Schwartz formula) or requirement for dialysis. eGFR retesting during the screening period is allowed (once).
• Active infective endocarditis
• Subjects with 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
• 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
• 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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

University of California Davis

Sacramento, California, United States

University of Miami

Miami, Florida, United States

St. Joseph's Children's Hospital

Tampa, Florida, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Alliance for Childhood Diseases

Las Vegas, Nevada, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States

AKH - Medical University of Vienna

Vienna, , Austria

Brussels - UNIV UZ Brussel

Brussels, , Belgium

UNIV UZ Gent

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

Campinas, , Brazil

Faculdade de Ciencias Medicas da UNICAMP

Campinas, , Brazil

Instituto de Oncologia Pediatrica - IOP / GRAAC - UNIFESP

São Paulo, , Brazil

Kingston General Hospital

Kingston, Ontario, Canada

CHU Sainte-Justine

Montreal, Ontario, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

University Hospital Brno

Brno, , Czechia

University Hospital Olomouc

Olomouc, , Czechia

University Hospital Ostrava

Ostrava, , Czechia

University Hospital Plzen, Plzen-Lochotin

Plzen - Lochotin, , Czechia

University Hospital Motol

Prague, , Czechia

Rigshospitalet, København, Børneonkologisk Afsnit 5002

Copenhagen, , Denmark

HOP Timone

Marseille, , France

Universitätsklinikum Essen AöR

Essen, , Germany

Universitätsmedizin Göttingen, Georg-August-Universität

Göttingen, , Germany

Universitätsklinikum Münster

Münster, , Germany

University Debrecen Hospital

Debrecen, , Hungary

Shaare Zedek Medical Center, Jerusalem 91031

Jerusalem, , Israel

A.O. Univ. Policlinico "Paolo Giaccone"

Palermo, , Italy

Università degli Studi "La Sapienza"

Roma, , Italy

Osp. Pediatrico Bambin Gesù

Roma, , Italy

Ospedale Infantile Regina Margherita

Torino, , Italy

Children Intensive Care Hosp,Anaesthesiology Dept,Vilnius

Vilnius, , Lithuania

Instituto Nacional de Pediatría

Mexico City, , Mexico

Haukeland Universitetssykehus

Bergen, , Norway

Oslo Universitetssykehus HF, Rikshospitalet

Oslo, , Norway

Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan

Kazan', , Russia

Science Res.Instit.CV Diseases,Scientific Res.Dept,Kemerovo

Kemerovo, , Russia

Morozovskaya Children Clin.Hosp.,Haematological Dept, Moscow

Moscow, , Russia

Child.CityClin.Hos.na.ZA Bashlyaeva MoscowHealth Dep,Cardiol

Moscow, , Russia

St.Petersburg State Pediatric Univ.Ministry of Healthcare RF

Saint Petersburg, , Russia

Reg Clin.Hosp.#1,Healthcare Tyumen Region,Cardiovas.Surgery

Tyument, , Russia

State Budget Healthcare Institution "Republican children's clinical hospital"

Ufa, , Russia

Childr.CityClin.Hos#9,pediatric&Neonatal Neurol.Ekaterinburg

Yekaterinburg, , Russia

Karolinska Univ. sjukhuset

Solna, , Sweden

Universitäts-Kinderspital

Zurich, , Switzerland

Taichung Veterans General Hospital

Taichung, , Taiwan

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Cukurova Universitesi Tip Fakultesi Cocuk Sagligi

Adana, , Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi

Ankara, , Turkey (Türkiye)

Akdeniz Universitesi Tip Fakultesi

Antalya, , Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, , Turkey (Türkiye)

Istanbul Saglik Bilimleri Uni. Kanuni Sultan Suleyman EAH

Istanbul, , Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Cocuk Hematolojisi Bilim Dali

Izmir, , Turkey (Türkiye)

Necmettin Erbakan Universitesi Meram Tip Fakultesi

Konya, , Turkey (Türkiye)

Reg.Children Hosp.Dnipropetrovsk

Dnipropetrovsk, , Ukraine

Western Ukrainian Spec.Children Med.Center,Lviv

Lviv, , Ukraine

Reg.Children Hosp,Vinnytsia

Vinnytsia, , Ukraine

Countries

United States; Austria; Belgium; Brazil; Canada; Czechia; Denmark; France; Germany; Hungary; Israel; Italy; Lithuania; Mexico; Norway; Russia; Sweden; Switzerland; Taiwan; Thailand; Turkey (Türkiye); Ukraine

References

Albisetti M, Tartakovsky I, Halton J, Bomgaars L, Chalmers E, Mitchell LG, Luciani M, Nurmeev I, Gorbatikov K, Miede C, Brueckmann M, Brandao LR; Study Investigators. Dabigatran for Treatment and Secondary Prevention of Venous Thromboembolism in Pediatric Congenital Heart Disease. J Am Heart Assoc. 2024 Feb 20;13(4):e028957. doi: 10.1161/JAHA.122.028957. Epub 2024 Feb 13.

Reference Type: DERIVED

PMID: 38348778 (View on PubMed)

Brandao LR, Tartakovsky I, Albisetti M, Halton J, Bomgaars L, Chalmers E, Luciani M, Saracco P, Felgenhauer J, Lvova O, Simetzberger M, Sun Z, Mitchell LG. Dabigatran in the treatment and secondary prophylaxis of venous thromboembolism in children with thrombophilia. Blood Adv. 2022 Nov 22;6(22):5908-5923. doi: 10.1182/bloodadvances.2021005681.

Reference Type: DERIVED

PMID: 36150047 (View on PubMed)

Brandao LR, Albisetti M, Halton J, Bomgaars L, Chalmers E, Mitchell LG, Nurmeev I, Svirin P, Kuhn T, Zapletal O, Tartakovsky I, Simetzberger M, Huang F, Sun Z, Kreuzer J, Gropper S, Brueckmann M, Luciani M; DIVERSITY Study Investigators. Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children. Blood. 2020 Feb 13;135(7):491-504. doi: 10.1182/blood.2019000998.

Reference Type: DERIVED

PMID: 31805182 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.boehringer-ingelheim.com/

Related Info

Other Identifiers

2014-000583-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1160.108

Identifier Type: -

Identifier Source: org_study_id