Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)

PHASE3CompletedINTERVENTIONAL
Enrollment

267

Participants

Timeline

Start Date

September 25, 2013

Primary Completion Date

October 16, 2019

Study Completion Date

November 14, 2019

Conditions
Venous Thromboembolism
Interventions
DRUG

dabigatran etexilate

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

DRUG

standard of care

Low molecular weight heparin, vitamin K antagonist or fondaparinux prescribed in an open label fashion for 3 months (these medications will not supplied in this study as IMP)

Trial Locations (65)

407

Taichung Veterans General Hospital, Taichung

1090

AKH - Medical University of Vienna, Vienna

1200

Brussels - UNIV Saint-Luc, Brussels

1330

Cukurova Universitesi Tip Fakultesi Cocuk Sagligi, Adana

2100

Rigshospitalet, København, Børneonkologisk Afsnit 5002, Copenhagen

3000

UZ Leuven, Leuven

4032

University Debrecen Hospital, Debrecen

6020

Medical University of Innsbruck, Innsbruck

7058

Akdeniz Universitesi Tip Fakultesi, Antalya

8032

Universitäts-Kinderspital, Zurich

9000

UNIV UZ Gent, Ghent

10126

Ospedale Infantile Regina Margherita, Torino

10330

King Chulalongkorn Memorial Hospital, Bangkok

11527

"Aghia Sophia Children's Hospital", Athens

15006

University Hospital Motol, Prague

21029

Reg.Children Hosp,Vinnytsia, Vinnytsia

22908

University of Virginia Health System, Charlottesville

27157

Wake Forest University Health Sciences, Winston-Salem

28009

Hospital Infantil Universitario Niño Jesus, Madrid

29609

HOP de la Cavale Blanche, Brest

33136

University of Miami, Miami

33520

TaUH, Pediatric Early Phase Trial Unit, Tampere

33607

St. Joseph's Children's Hospital, Tampa

34098

Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul

34303

Istanbul Saglik Bilimleri Uni. Kanuni Sultan Suleyman EAH, Istanbul

35040

Ege Universitesi Tip Fakultesi Cocuk Hematolojisi Bilim Dali, Izmir

41345

Sahlgrenska US, Göteborg, Gothenburg

42080

Necmettin Erbakan Universitesi Meram Tip Fakultesi, Konya

45147

Universitätsklinikum Essen AöR, Essen

48149

Universitätsklinikum Münster, Münster

49100

Reg.Children Hosp.Dnipropetrovsk, Dnipropetrovsk

50309

Blank Children's Hospital, Des Moines

52242

University of Iowa Hospitals and Clinics, Iowa City

61300

University Hospital Brno, Brno

64460

Hospital Universitario Dr Jose Eleuterio Gonzalez, Nuevo León

70852

University Hospital Ostrava, Ostrava

77900

University Hospital Olomouc, Olomouc

95817

University of California Davis, Sacramento

99204

Providence Sacred Heart Medical Center and Children's Hospital, Spokane

105077

Izmilovskaya Child City ClinHosp,Haematological Dept, Moscow, Moscow

125373

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

194100

St.Petersburg State Pediatric Univ.Ministry of Healthcare RF, Saint Petersburg

420138

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

620134

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

625023

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

650002

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

9103102

Shaare Zedek Medical Center, Jerusalem 91031, Jerusalem

02115

Boston Children's Hospital, Boston

C1270AAN

Hospital General de Niños Pedro de Elizalde, CABA

13059-740

HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas, Campinas

13083-970

Faculdade de Ciencias Medicas da UNICAMP, Campinas

01227-200

PenSI - Pesquisa e Ensino em Saude Infantil, São Paulo

05403-000

Instituto de Crianca / Hospital das Clínicas-FMUSP, São Paulo

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

The Hospital for Sick Children, Toronto

H3T 1C5

CHU Sainte-Justine, Montreal

500 05

General Univ.hosp Hradec Kralove, Hradec Králové

304 60

University Hospital Plzen, Plzen-Lochotin, Plzen-Lochotin

00161

"Università degli Studi La Sapienza", Roma

08406

Children Intensive Care Hosp,Anaesthesiology Dept,Vilnius, Vilnius

04530

Instituto Nacional de Pediatría, México D.F

N-5021

Haukeland Universitetssykehus, Bergen

N-0372

Oslo Universitetssykehus HF, Rikshospitalet, Oslo

171 65

Karolinska Univ. sjukhuset, Solna

06100

Hacettepe Universitesi Tip Fakultesi, Ankara

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT01895777 - Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE) | Biotech Hunter | Biotech Hunter