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ACTIVE NOT RECRUITING
NCT04158934

A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A

Sponsor: Baxalta now part of Shire

View on ClinicalTrials.gov

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

BIOLOGICAL

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