Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
951 participants
OBSERVATIONAL
2011-06-28
2024-01-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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rAHF-PFM
Participants treated with rAHF-PFM alone
ADVATE
Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
rAHF-PEG
Participants treated with rAHF-PEG alone
ADYNOVI
Antihemophilic Factor (Recombinant) Pegylated
rAHF-PFM then rAHF-PEG
Participants treated with rAHF-PFM and subsequently switched to rAHF-PEG
ADVATE
Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
ADYNOVI
Antihemophilic Factor (Recombinant) Pegylated
Interventions
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ADVATE
Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
ADYNOVI
Antihemophilic Factor (Recombinant) Pegylated
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is prescribed Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) by the treating physician
* Participant or participant's legally authorized representative provides informed consent
Exclusion Criteria
* Participant has known allergic reaction to mouse or hamster proteins
* Participant has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving another FVIII concentrate or device during the course of this study
ALL
No
Sponsors
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Baxalta Innovations GmbH, now part of Shire
INDUSTRY
Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
South Metropolitan Health Service trading as Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Landes Frauen und Kinderklinik Linz (LFKK Linz)
Linz, , Austria
Kepler Universitätsklinikum Klinik für Kinder-und Jugendheilkunde
Linz, , Austria
Medizinische Universitaet Wien
Vienna, , Austria
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Hemoce - Ce
Fortaleza, Ceará, Brazil
Hemocentro do Espírito Santo
Vitória, Espírito Santo, Brazil
Hemepar - Pr
Curitiba, Paraná, Brazil
Hemorgs - Rs
Porto Alegre, Parthenon, Brazil
Fundação HEMOPA
Belém, Pará, Brazil
Hemocentro da UNICAMP
Campinas, São Paulo, Brazil
Hemocentro Ribeirão Preto - SP
Ribeirão Preto, São Paulo, Brazil
Hemorio - Rj
Rio de Janeiro, , Brazil
Faculdade de Medicina da Universidade de São Paulo
São Paulo, , Brazil
Stollery Children's Hospital, University of Alberta
Edmonton, Alberta, Canada
The Moncton City Hospital
Moncton, New Brunswick, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
St-Michael's Hospital
Toronto, Ontario, Canada
Sick Kids Hospital
Toronto, Ontario, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Shenzhen Children's Hospital
Shenzhen, Futian, China
Nanfang Hospital Affiliated to Nanfang Medical University
Guangzhou, Guangdong, China
Institute of Hematology, Blood Disease Hospital, PUMC&CAMS
Tianjin, Heping, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The Blood Center of Shandong Province
Jinan, Shandong, China
Beijing Children's Hospital Affiliated to Capital University of Medical Sciences
Beijing, , China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, , China
Shenzhen Second People's Hospital
Shenzhen, , China
IPS FUSA SAS Centro Integral de Coagulacion
Atlántico, , Colombia
Integral Solutions SD SAS
Bogotá, , Colombia
Fundación Oftalmológica de Santander FOSCAL
Floridablanca, , Colombia
Fakultní nemocnice Brno
Brno, , Czechia
Fakultní nemocnice Ostrava, Oddělení dětské hematologie a hematoonkologie
Ostrava, , Czechia
Fakultní nemocnice Ostrava
Ostrava, , Czechia
Fakultní nemocnice v Motole
Prague, , Czechia
Rigshospitalet
Copenhagen, , Denmark
"Hôpital Morvan CHRU de Brest"
Brest, , France
CHU Côte de Nacre - CRTH
Caen, , France
Centre Hospitalier Générale - CTH
Chambéry, , France
CTRH - CHU Bocage
Dijon, , France
Hôpital André Mignot
Le Chesnay, , France
Hôpital de la Mère et de l'Enfant - CHU de LIMOGES
Limoges, , France
CHRU Hôtel Dieu - CRTH
Nantes, , France
Hôpital Cochin
Paris, , France
CHU de Reims Hôpital Maison Blanche - CRTH
Reims, , France
Centre Régional de Traitement de l'Hémophilie et des Maladies hémorragiques. CHU de Rennes - Hôpital Pontchaillou
Rennes, , France
CHRU Charles Nicolle
Rouen, , France
CIC
Saint-Priest-en-Jarez, , France
CHRU Purpan CRTH - Pavillon Sénac
Toulouse, , France
Aghia Sofia Children's Hospital
Goudi, Athens, Greece
Laikon General Hospital
Goudi, Athens, Greece
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki, , Greece
Heim Pál Gyermekkórház
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Mohács City Hospital
Mohács, , Hungary
Jósa András County Hospital
Nyíregyháza, , Hungary
Markusovszky Hospital
Szombathely, , Hungary
Azienda Ospedaliera Policlinico Consorziale Di Bari
Bari, , Italy
Policlinico S Orsola Malpighi
Bologna, , Italy
Azienda Ospedaliera Universitaria Vittorio Emanuele, Ferrarotto, S. Bambino
Catania, , Italy
Ospedale Pugliese -Ciaccio
Catanzaro, , Italy
Az. Osp. Univ. Careggi
Florence, , Italy
Ospedale di Macerata
Macerata, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Azienda Ospedaliera di Padova Clinica Medica II
Padua, , Italy
AOUP P. Giaccone
Palermo, , Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria, , Italy
Università degli studi di Roma "La Sapienza"
Roma, , Italy
Ospedale Pediatrico Bambino Gesù
Roma, , Italy
Policlinico Universitario Gemelli
Roma, , Italy
Centro Emofilia e Coagulopatie Rare
Scorrano, , Italy
Ospedale Molinette
Torino, , Italy
Rikshospitalet
Oslo, , Norway
Rikshospitalet, Oslo University Hospital
Oslo, , Norway
Szpital Uniwersytecki nr 1 im. dr Andrzeja Jurasza
Bydgoszcz, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1
Gdansk, , Poland
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny we Wrocławiu
Wroclaw, , Poland
Hospital do Divino Espírito Santo
Ponta Delgada, Azores, Portugal
Centro Hospitalar e Universitade de Coimbra
Coimbra, , Portugal
Centro Hospitalar Lisboa Norte Hospital de Sta. Maria
Lisbon, , Portugal
Centro Hospitalar de São João, E.P.E.
Porto, , Portugal
SBHI Chelyabinsk Regional Children's Clinical Hospital
Chelyabinsk, , Russia
Federal State Budget Institution "Hematology Research Center" of Ministry of Healthcare of Russian Federation
Moscow, , Russia
SBHI of the Republic of Kareliya Republican Hospital n.a. V.A. Baranov
Petrozavodsk, , Russia
State Budget Healthcare Institution of Saint-Petersburg "City polyclinic #37"
Saint Petersburg, , Russia
Clinics of FSBEI High Education Samara SMU of MoH of Russia
Samara, , Russia
University Medical Centre Ljubljana
Ljubljana, , Slovenia
Hospital Teresa Herrera-Materno Infantil
A Coruña, , Spain
Hospital Hospital Sant Joan de Déu
Barcelona, , Spain
Hospital Universitari Vall d'Hebron (HUVH)
Barcelona, , Spain
Hospital Universitario Son Espases
Palma de Mallorca, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Kliniska studier i Sverige - Forum Söder
Malmo, , Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, , Sweden
Universitätsspital Basel
Basel, , Switzerland
Inselspital Bern
Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Luzerner Kantonsspital
Lucerne, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
FMH Kinder und Jugendmedizin, im Wabern-Zentrum
Wabern, , Switzerland
Kinderspital Zürich
Zurich, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Hampshire Hospitals NHS Foundation Trust, Basingstoke and North Hampshire Hospital
Basingstoke, Hampshire, United Kingdom
Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital
Cambridge, , United Kingdom
East Kent Hospitals University Foundation Trust, Kent & Canterbury Hospital
Canterbury, , United Kingdom
Great Ormond Street Hospital for Children NHS Trust
London, , United Kingdom
Countries
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References
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Ozelo MC, Hermans C, Carcao M, Guillet B, Gu J, Guerra R, Tang L, Khair K. The effectiveness and safety of octocog alfa in patients with hemophilia A: up to 7-year follow-up of the real-world AHEAD international study. Ther Adv Hematol. 2024 Feb 15;15:20406207231218624. doi: 10.1177/20406207231218624. eCollection 2024.
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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061001
Identifier Type: -
Identifier Source: org_study_id
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