Actively Recruiting

All Genders
NCT03695978

Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients

Led by Octapharma · Updated on 2025-11-10

200

Participants Needed

55

Research Sites

641 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.

CONDITIONS

Official Title

Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients of any age and ethnicity
  • Severe haemophilia A with factor VIII activity less than 1%
  • Decision to prescribe Octapharma's FVIII concentrate before enrolling in the study
  • Either no previous treatment with FVIII concentrates or blood products containing FVIII (PUPs) OR fewer than 5 exposure days to such products (MTPs), if treatment history is known
  • Patients who did not develop an inhibitor at any time or developed an inhibitor during treatment with an Octapharma FVIII concentrate and continue treatment with the same product
  • Voluntarily given fully informed written and signed consent obtained before any study-related data collection (from patient or legal guardian)
Not Eligible

You will not qualify if you...

  • Diagnosis with a coagulation disorder other than haemophilia A
  • Receiving systemic immunosuppressive drugs
  • Participating in an interventional clinical trial during the study period
  • Participating in another non-interventional study by Octapharma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 55 locations

1

University of Miami Miller School of Medicine

Miami, Florida, United States, 33136

Active, Not Recruiting

2

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

Actively Recruiting

3

Cure 4 The Kids Foundation Children's Specialty Center

Las Vegas, Nevada, United States, 89109

Withdrawn

4

CENIDOR

Salta, Argentina

Active, Not Recruiting

5

Azerbaijan State Advanced Training Institute for Doctors Hematology Department Scientific-Research Center of Hemophilia

Baku, Azerbaijan, AZ1012

Withdrawn

6

Republican Scientific Center for Radiation Medicine and Human Ecology

Homyel, Belarus, 246040

Withdrawn

7

Republican Scientific and Practical Centre of Children Oncology, Hematology and Immunology

Minsk, Belarus, 223053

Actively Recruiting

8

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, Belgium, 1020

Actively Recruiting

9

Cliniques Universitaires Saint-Luc

Brussels, Belgium, 1200

Actively Recruiting

10

Cliniques Universitaires Saint-Luc

Brussels, Belgium, 1200

Actively Recruiting

11

McMaster University, Division of Pediatric Hematology/Oncology Room 3N27

Hamilton, Ontario, Canada, 1800NOCLOTS

Withdrawn

12

Department of Hematology Research Research Transition Facility

Edmonton, Canada, T6G 2V2

Completed

13

University Hospital Centre Zagreb

Zagreb, Croatia

Actively Recruiting

14

Tallinn Childrenś Hospital Clinic of Paediatric Department of Haematology and Oncology

Tallinn, Estonia, 13419

Withdrawn

15

CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON

Besançon, France

Actively Recruiting

16

CHRU Tours - Hôpital Trousseau

Chambray-lès-Tours, France

Actively Recruiting

17

Centre Régional de Traitement de l'hémophilie

Le Mans, France

Actively Recruiting

18

Hopital Simone Veil Groupement Hospitalier Eaubonne-Montmorency

Montmorency, France, 95160

Actively Recruiting

19

CHU Hotel Dieu, Centre de Traitment de l'Hemophilie

Nantes, France, 44093

Actively Recruiting

20

Hôspital Necker Enfants Malades

Paris, France

Actively Recruiting

21

CHRU Hopital Nord, Secretariat de pediatre, bat E niv +3

Saint-Priest-en-Jarez, France, 42270

Actively Recruiting

22

Vivantes - Netzwerk für Gesundheit GmbH Klinikum im Friedrichshain

Berlin, Germany, 10249

Active, Not Recruiting

23

Institute of Experimental Haematology and Transfusion Medicine (IHT) University Clinic Bonn (AöR)

Bonn, Germany, 53127

Actively Recruiting

24

Coagulation Research Centre GmbH

Duisburg, Germany, 47051

Actively Recruiting

25

University Hospital Essen

Essen, Germany

Active, Not Recruiting

26

HZRM GmbH

Frankfurt, Germany

Active, Not Recruiting

27

Heim Pál National Pediatric Institute Department of Oncology and Hematology

Budapest, Hungary, 1089

Actively Recruiting

28

University of Debrecen Department of Pediatrics

Debrecen, Hungary, 4032

Actively Recruiting

29

Ospedale Pediatrico "Giovani XXIII"

Bari, Italy

Actively Recruiting

30

Policlinico Sant'Orsola Malpighi

Bologna, Italy, 40138

Actively Recruiting

31

Ospedale San Giacomo

Castelfranco Veneto, Italy, 31033

Completed

32

Azienda Ospedaliera-Universitaria Policlinico "Vittorio Emanuele", Centro di Riferimento Regionale per la Prevenzione, Diagnosi e Cura delle Malattie Rare della Coagulazione nel Bambino e neel'Adulto. U.O.C Ematologia con trapianto di Midollo Osseo

Catania, Italy, 95123

Actively Recruiting

33

Azienda Ospedaliero Universitaria Careggi

Florence, Italy, 50134

Actively Recruiting

34

Ospedale Maggiore Policlinico

Milan, Italy, 920122

Actively Recruiting

35

Center for Thrombosis and Hemorrhagic Diseases, IRCCS Humanitas Research Hospital

Milan, Italy

Actively Recruiting

36

Centro Emofilia - AUO di Padova

Padova, Italy

Withdrawn

37

Policlinico Umberto I

Rome, Italy, 00161

Actively Recruiting

38

C.tro Emofilia A.O. Città della salute e della scienza di Torino, Ospedale Regina Margherita

Torino, Italy

Actively Recruiting

39

Ospedale Regina Margherita

Turin, Italy, 10126

Withdrawn

40

Children's Hospital Affiliate of Vilnius Universtity Hospital Santaros Klinikos

Vilnius, Lithuania, LT-08406

Actively Recruiting

41

Hospital Infantil de Morelia Eva Sámano de López Mateos

Morelia, Mexico

Actively Recruiting

42

Hospital Universitario Dr. José Eleuterio Gonzalez S/N

Nuevo León, Mexico

Actively Recruiting

43

SMO and Scientific Services S.A.P.P de C.V

Nuevo León, Mexico

Actively Recruiting

44

Moscow State Government-financed Public Healthcare Institution "Morozovskaya Children Clinical Hospital of Moscow Healthcare Department"

Moscow, Russia, 119049

Withdrawn

45

Saint-Petersburg State Budget Healthcare Institution "City Out-patient Clinical # 37"

Saint Petersburg, Russia, 191186

Withdrawn

46

Hospital General Universitario de Alicante Hematología y Hemoterapia

Alicante, Spain, 03010

Actively Recruiting

47

Hospital Universitari Vall D'Hebrón, Unitat d'Hemofilia

Barcelona, Spain, 02035

Actively Recruiting

48

HRU Malaga

Málaga, Spain

Not Yet Recruiting

49

Universitary Hospital Son Espases (Hematology Service)

Palma de Mallorca, Spain

Active, Not Recruiting

50

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Active, Not Recruiting

51

Istanbul University Faculty of Medicine

Fatih, Turkey (Türkiye)

Withdrawn

52

John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust

Headington, Oxford, United Kingdom, OX3 9DU

Actively Recruiting

53

Birmingham Children's Hospital NHS Foundation Trust

Birmingham, United Kingdom, B46NH

Withdrawn

54

Great Ormond Street Hospital for Children NHS Trust, Haemophilia Centre

London, United Kingdom, WC1N 3JH

Actively Recruiting

55

Newcastle Haemophilia Comprehensive Care Centre, Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom, NE1 4LP

Actively Recruiting

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Research Team

C

Cristina Solomon, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients | DecenTrialz