ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)
AHEAD
1 other identifier
observational
951
21 countries
108
Brief Summary
The purpose of the study is to document the natural history of hemophilia A disease and long-term outcomes in terms of effectiveness, safety and quality of life in participants receiving Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) in routine clinical practice
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2011
Longer than P75 for all trials
108 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 28, 2011
CompletedFirst Submitted
Initial submission to the registry
March 3, 2014
CompletedFirst Posted
Study publicly available on registry
March 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2024
CompletedJune 17, 2024
June 1, 2024
12.6 years
March 3, 2014
June 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Joint Health Outcomes - Assessed by Physical Exam Using Only the Pain, Bleeding, and Physical Exam Parameters of the Gilbert Scale
The World Federation of Hemophilia developed a musculoskeletal evaluation system, commonly referred to as the Gilbert test, to measure hemophilia joint health status.The Gilbert test needs to be performed in the absence of acute bleed, acute pain, and acute inflammation into the evaluated joint. Four parameters are used in each Gilbert test: pain (score: 0-3), bleeding (score: 0-3), physical exam (score: 0-12), and X-ray evaluation (score: 0-13) Scores of 0, represent no pain, no bleeding, no physical exam issues, and/or no x-ray issues. Higher scores for each of these categories represents worsening conditions.
Up to approximately 12 years
Secondary Outcomes (32)
Annualized Bleed Rate, All Joints
Annual/Interval visits:- Up to 8 years if rAHF-PFM alone- Up to 8 years if rAHF-PEG alone with minimum follow up of 4 years- Up to approx. 12 years rAHF-PFM and switched to rAHF-PEG; and Termination visit
Annualized Bleed Rate, All Bleeds
Annual/Interval visits:- Up to 8 years if rAHF-PFM alone- Up to 8 years if rAHF-PEG alone with minimum follow up of 4 years- Up to approx. 12 years rAHF-PFM and switched to rAHF-PEG; and Termination visit
Annualized bleed rate, pre-existing target joints at baseline
Screening visit; Annual/Interval visits:- Up to 8 years if rAHF-PFM alone- Up to 8 years if rAHF-PEG alone with minimum follow up of 4 years- Up to approx. 12 years rAHF-PFM and switched to rAHF-PEG; and Termination visit
Incidence of New Target Joints
Screening visit; Annual/Interval visits:- Up to 8 years if rAHF-PFM alone- Up to 8 years if rAHF-PEG alone with minimum follow up of 4 years- Up to approx. 12 years rAHF-PFM and switched to rAHF-PEG; and Termination visit
Status of joint health by X-ray by Pettersson scale
Screening visit; Annual/Interval visits:- Up to 8 years if rAHF-PFM alone- Up to 8 years if rAHF-PEG alone with minimum follow up of 4 years- Up to approx. 12 years rAHF-PFM and switched to rAHF-PEG; and Termination visit.
- +27 more secondary outcomes
Study Arms (3)
rAHF-PFM
Participants treated with rAHF-PFM alone
rAHF-PEG
Participants treated with rAHF-PEG alone
rAHF-PFM then rAHF-PEG
Participants treated with rAHF-PFM and subsequently switched to rAHF-PEG
Interventions
Eligibility Criteria
The study population will include male and female participants of any race and age who have a diagnosis of hemophilia A (Factor VIII (FVIII) =5%). Participants must have been prescribed rAHF-PFM or rAHF-PEG for the management of hemophilia A by the treating physician prior to the decision to enroll in the study.
You may qualify if:
- Participant has hemophilia A {FVIII lesser than or equal to (\<=)5%}
- 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
You may not qualify if:
- Participant has known hypersensitivity to the active substance or any of the excipients
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (110)
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
South Metropolitan Health Service trading as Fiona Stanley Hospital
Murdoch, Western Australia, 6050, Australia
Landes Frauen und Kinderklinik Linz (LFKK Linz)
Linz, 4017, Austria
Kepler Universitätsklinikum Klinik für Kinder-und Jugendheilkunde
Linz, 4020, Austria
Medizinische Universitaet Wien
Vienna, 1090, Austria
Cliniques Universitaires Saint-Luc
Brussels, B-1200, Belgium
Hemoce - Ce
Fortaleza, Ceará, 60431086, Brazil
Hemocentro do Espírito Santo
Vitória, Espírito Santo, 29040-090, Brazil
Hemepar - Pr
Curitiba, Paraná, 80045-145, Brazil
Hemorgs - Rs
Porto Alegre, Parthenon, 90650-000, Brazil
Fundação HEMOPA
Belém, Pará, 66033-000, Brazil
Hemocentro da UNICAMP
Campinas, São Paulo, 13083-970, Brazil
Hemocentro Ribeirão Preto - SP
Ribeirão Preto, São Paulo, 14051140, Brazil
Hemorio - Rj
Rio de Janeiro, 20211030, Brazil
Faculdade de Medicina da Universidade de São Paulo
São Paulo, 5403000, Brazil
Stollery Children's Hospital, University of Alberta
Edmonton, Alberta, T6G 2B7, Canada
The Moncton City Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
St-Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Sick Kids Hospital
Toronto, Ontario, M5G 1X8, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, 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, 221006, China
The Blood Center of Shandong Province
Jinan, Shandong, China
Beijing Children's Hospital Affiliated to Capital University of Medical Sciences
Beijing, 100045, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
Shenzhen Second People's Hospital
Shenzhen, 518037, China
IPS FUSA SAS Centro Integral de Coagulacion
Atlántico, Colombia
Integral Solutions SD SAS
Bogotá, Colombia
Fundación Oftalmológica de Santander FOSCAL
Floridablanca, 681004, Colombia
Fakultní nemocnice Brno
Brno, 613 00, Czechia
Fakultní nemocnice Ostrava, Oddělení dětské hematologie a hematoonkologie
Ostrava, 70852, Czechia
Fakultní nemocnice Ostrava
Ostrava, 70852, Czechia
Fakultní nemocnice v Motole
Prague, 150 06, Czechia
Rigshospitalet
Copenhagen, 2100, Denmark
"Hôpital Morvan CHRU de Brest"
Brest, 29200, France
CHU Côte de Nacre - CRTH
Caen, 14033, France
Centre Hospitalier Générale - CTH
Chambéry, 73011, France
CTRH - CHU Bocage
Dijon, 21079, France
Hôpital André Mignot
Le Chesnay, 78157, France
Hôpital de la Mère et de l'Enfant - CHU de LIMOGES
Limoges, 87043, France
CHRU Hôtel Dieu - CRTH
Nantes, 44093, France
Hôpital Cochin
Paris, 75014, France
CHU de Reims Hôpital Maison Blanche - CRTH
Reims, 51092, France
Centre Régional de Traitement de l'Hémophilie et des Maladies hémorragiques. CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033, France
CHRU Charles Nicolle
Rouen, 76031, France
CIC
Saint-Priest-en-Jarez, 42270, France
CHRU Purpan CRTH - Pavillon Sénac
Toulouse, 31059, France
Aghia Sofia Children's Hospital
Goudi, Athens, 11527, Greece
Laikon General Hospital
Goudi, Athens, 11527, Greece
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki, 546 42, Greece
Heim Pál Gyermekkórház
Budapest, H-1089, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, H-4032, Hungary
Mohács City Hospital
Mohács, H-7700, Hungary
Jósa András County Hospital
Nyíregyháza, H-4400, Hungary
Markusovszky Hospital
Szombathely, H-9700, Hungary
Azienda Ospedaliera Policlinico Consorziale Di Bari
Bari, 70124, Italy
Policlinico S Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Vittorio Emanuele, Ferrarotto, S. Bambino
Catania, 95120, Italy
Ospedale Pugliese -Ciaccio
Catanzaro, 88100, Italy
Az. Osp. Univ. Careggi
Florence, 50134, Italy
Ospedale di Macerata
Macerata, 62100, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131, Italy
Azienda Ospedaliera di Padova Clinica Medica II
Padua, 35100, Italy
AOUP P. Giaccone
Palermo, 90133, Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria, 89123, Italy
Università degli studi di Roma "La Sapienza"
Roma, 00161, Italy
Ospedale Pediatrico Bambino Gesù
Roma, 00165, Italy
Policlinico Universitario Gemelli
Roma, 00168, Italy
Centro Emofilia e Coagulopatie Rare
Scorrano, 73025, Italy
Ospedale Molinette
Torino, 10126, Italy
Rikshospitalet
Oslo, N-0027, Norway
Rikshospitalet, Oslo University Hospital
Oslo, N-0424, Norway
Szpital Uniwersytecki nr 1 im. dr Andrzeja Jurasza
Bydgoszcz, 85-094, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1
Gdansk, 80-952, Poland
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Warsaw, 02-091, Poland
Uniwersytecki Szpital Kliniczny we Wrocławiu
Wroclaw, 50-556, Poland
Hospital do Divino Espírito Santo
Ponta Delgada, Azores, 9500-370, Portugal
Centro Hospitalar e Universitade de Coimbra
Coimbra, 3000-602, Portugal
Centro Hospitalar Lisboa Norte Hospital de Sta. Maria
Lisbon, 1649-035, Portugal
Centro Hospitalar de São João, E.P.E.
Porto, 4200-319, 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, 125167, 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, 191186, Russia
Clinics of FSBEI High Education Samara SMU of MoH of Russia
Samara, 443079, Russia
University Medical Centre Ljubljana
Ljubljana, SI-1000, Slovenia
Hospital Teresa Herrera-Materno Infantil
A Coruña, 15006, Spain
Hospital Hospital Sant Joan de Déu
Barcelona, 08035, Spain
Hospital Universitari Vall d'Hebron (HUVH)
Barcelona, 08035, Spain
Hospital Universitario Son Espases
Palma de Mallorca, 07120, Spain
Sahlgrenska University Hospital
Gothenburg, SE 41345, Sweden
Kliniska studier i Sverige - Forum Söder
Malmo, SE-205 02, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
Universitätsspital Basel
Basel, CH-4031, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011, Switzerland
Luzerner Kantonsspital
Lucerne, CH-6000, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, 9007, Switzerland
FMH Kinder und Jugendmedizin, im Wabern-Zentrum
Wabern, CH-3084, Switzerland
Kinderspital Zürich
Zurich, CH-8032, Switzerland
Universitätsspital Zürich
Zurich, CH-8091, Switzerland
Hampshire Hospitals NHS Foundation Trust, Basingstoke and North Hampshire Hospital
Basingstoke, Hampshire, RG24 9NA, United Kingdom
Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
East Kent Hospitals University Foundation Trust, Kent & Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
Great Ormond Street Hospital for Children NHS Trust
London, WC1N 3JH, United Kingdom
Related Publications (1)
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.
PMID: 38371314DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2014
First Posted
March 5, 2014
Study Start
June 28, 2011
Primary Completion
January 16, 2024
Study Completion
January 16, 2024
Last Updated
June 17, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.