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A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A
Sponsor: Baxalta now part of Shire
Summary
The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.
Official title: Evaluation of Long-term Safety of ADYNOVI/ADYNOVATE (Antihaemophilic Factor [Recombinant] PEGylated, Rurioctocog Alfa Pegol) in Patients With Haemophilia A - An ADYNOVI/ADYNOVATE Post-Authorisation Safety Study (PASS)
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
207
Start Date
2020-07-09
Completion Date
2030-02-28
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
ADYNOVI/ADYNOVATE
Participants will receive ADYNOVI/ADYNOVATE prescribed prophylactically by physicians based on their standard clinical practice and in accordance with the national SmPC.
Locations (36)
UF Health Shands Hospital
Gainesville, Florida, United States
SHAT of Oncohaematology Diseases
Sofia, Bulgaria
Clinical Hospital Sveti Duh
Zagreb, Croatia
University hospital centre Zagreb
Zagreb, Croatia
University hospital centre Zagreb
Zagreb, Croatia
Fakultni nemocnice v Motole
Prague, Czechia
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
Ústí nad Labem, Czechia
SRH Kurpfalzkrankenhaus Heidelberg GmbH
Heidelberg, Baden-Wurttemberg, Germany
Vivantes Klinikum im Friedrichshain
Berlin, Germany
Universitaetsklinikum Bonn AoeR
Bonn, Germany
Werlhof-Institut GmbH
Hanover, Germany
Heim Pal Orszagos Gyermekgyogyaszati Intezet
Budapest, Hungary
Eszak-Pesti Centrumkorhaz - Honvedkorhaz
Budapest, Hungary
Debreceni Egyetem
Debrecen, Hungary
Mohacsi Korhaz
Mohács, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Nyíregyháza, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Hungary
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
University Medical Centre Groningen-UMCG
Groningen, Netherlands
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Regional Universitario de Malaga
Málaga, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
MacKay Memorial Hospital_Taipei Branch
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkoknoi Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand