RecruitingNCT03695978

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

Practical Utilisation of Octapharma FVIII Concentrates in Previously Untreated & Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment With Nuwiq, Octanate or Wilate - Efficacy & Safety Observational Study-Protect-NOW

Sponsor

Octapharma

Enrollment

200 participants

Start Date

Feb 13, 2018

Study Type

OBSERVATIONAL

Conditions

Haemophilia A

Summary

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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world data on the safety and effectiveness of Octapharma's clotting factor concentrates (Nuwiq, Octanate, and Wilate) in patients with severe hemophilia A who have never — or barely — been treated before. Hemophilia A is an inherited bleeding disorder caused by a deficiency of clotting factor VIII (FVIII), which means the blood cannot clot properly and even minor injuries can cause prolonged bleeding. Children and adults who have never received FVIII products before (or have had fewer than 5 treatment exposures) are of particular interest because they are at risk of developing inhibitors — antibodies that block the factor from working. This non-interventional study records outcomes in routine clinical practice without changing treatments. You may be eligible if: - You have severe hemophilia A (FVIII activity below 1%) - You have never received factor VIII treatment, or have had fewer than 5 exposure days - Your doctor has decided to prescribe an Octapharma FVIII product - You or your parent/guardian has provided informed consent You may NOT be eligible if: - You have another coagulation disorder in addition to hemophilia A - You are currently on systemic immunosuppressive drugs - You are enrolled in an interventional clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(55)

University of Miami Miller School of Medicine

Miami, Florida, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Cure 4 The Kids Foundation Children's Specialty Center

Las Vegas, Nevada, United States

CENIDOR

Salta, Argentina

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

Baku, Azerbaijan

Republican Scientific Center for Radiation Medicine and Human Ecology

Homyel, Belarus

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

Minsk, Belarus

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

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

Hamilton, Ontario, Canada

Department of Hematology Research Research Transition Facility

Edmonton, Canada

University Hospital Centre Zagreb

Zagreb, Croatia

Tallinn Childrenś Hospital Clinic of Paediatric Department of Haematology and Oncology

Tallinn, Estonia

CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON

Besançon, France

CHRU Tours - Hôpital Trousseau

Chambray-lès-Tours, France

Centre Régional de Traitement de l'hémophilie

Le Mans, France

Hopital Simone Veil Groupement Hospitalier Eaubonne-Montmorency

Montmorency, France

CHU Hotel Dieu, Centre de Traitment de l'Hemophilie

Nantes, France

Hôspital Necker Enfants Malades

Paris, France

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

Saint-Priest-en-Jarez, France

Vivantes - Netzwerk für Gesundheit GmbH Klinikum im Friedrichshain

Berlin, Germany

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

Bonn, Germany

Coagulation Research Centre GmbH

Duisburg, Germany

University Hospital Essen

Essen, Germany

HZRM GmbH

Frankfurt, Germany

Heim Pál National Pediatric Institute Department of Oncology and Hematology

Budapest, Hungary

University of Debrecen Department of Pediatrics

Debrecen, Hungary

Ospedale Pediatrico "Giovani XXIII"

Bari, Italy

Policlinico Sant'Orsola Malpighi

Bologna, Italy

Ospedale San Giacomo

Castelfranco Veneto, Italy

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

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Ospedale Maggiore Policlinico

Milan, Italy

Center for Thrombosis and Hemorrhagic Diseases, IRCCS Humanitas Research Hospital

Milan, Italy

Centro Emofilia - AUO di Padova

Padova, Italy

Policlinico Umberto I

Rome, Italy

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

Torino, Italy

Ospedale Regina Margherita

Turin, Italy

Children's Hospital Affiliate of Vilnius Universtity Hospital Santaros Klinikos

Vilnius, Lithuania

Hospital Infantil de Morelia Eva Sámano de López Mateos

Morelia, Mexico

Hospital Universitario Dr. José Eleuterio Gonzalez S/N

Nuevo León, Mexico

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

Nuevo León, Mexico

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

Moscow, Russia

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

Saint Petersburg, Russia

Hospital General Universitario de Alicante Hematología y Hemoterapia

Alicante, Spain

Hospital Universitari Vall D'Hebrón, Unitat d'Hemofilia

Barcelona, Spain

HRU Malaga

Málaga, Spain

Universitary Hospital Son Espases (Hematology Service)

Palma de Mallorca, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Istanbul University Faculty of Medicine

Fatih, Turkey (Türkiye)

John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust

Headington, Oxford, United Kingdom

Birmingham Children's Hospital NHS Foundation Trust

Birmingham, United Kingdom

Great Ormond Street Hospital for Children NHS Trust, Haemophilia Centre

London, United Kingdom

Newcastle Haemophilia Comprehensive Care Centre, Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

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NCT03695978

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