Prospective, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products
NCT ID: NCT02976753
Last Updated: 2024-10-02
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
361 participants
OBSERVATIONAL
2016-12-31
2021-11-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health
NCT04293523
A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
NCT03055611
rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A
NCT03951103
Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Participants
NCT03876301
POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies
NCT04690322
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Elocta
Elocta will be prescribed and administered for prophylactic treatment of patients with haemophilia A according to usual clinical practice
efmoroctocog alfa
extended half-life factor VIII product
Conventional factor VIII product
Conventional factor VIII products will be prescribed and administered for prophylactic treatment of patients with haemophilia A according to usual clinical practice
Factor VIII
conventional factor VIII product
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
efmoroctocog alfa
extended half-life factor VIII product
Factor VIII
conventional factor VIII product
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Received prophylactic treatment with a factor product for management of haemophilia A in the 12 months prior to enrolment
* At enrolment prescribed prophylactic treatment with Elocta or conventional factor product regardless of participation in the study
* Having at least 12 months documented pre-study treatment data regarding prophylactic treatment prescriptions and bleeding episodes prior to the baseline visit
* Signed and dated informed consent provided by the patient or the patient's legally acceptable representative for patients under the legal age before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations
Exclusion Criteria
* Previously treated with commercially available extended half-life products other than Elocta
* Presence of factor VIII inhibitors (≥0.60 Bethesda Unit \[BU\]/mL ) at the latest available inhibitor test using the Nijmegen modified Bethesda assay
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ICON plc
INDUSTRY
Swedish Orphan Biovitrum
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Physician, MD
Role: STUDY_DIRECTOR
Sweden Orphan Biovitrum
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Swedish Orphan Biovitrum Research site
Innsbruck, , Austria
Swedish Orphan Biovitrum Research site
Linz, , Austria
Swedish Orphan Biovitrum Research Site
Sankt Pölten, , Austria
Swedish Orphan Biovitrum Research site
Vienna, , Austria
Swedish Orphan Biovitrum Research site
Brussels, , Belgium
Swedish Orphan Biovitrum Research site
Helsinki, , Finland
Swedish Orphan Biovitrum Research site
Caen, , France
Swedish Orphan Biovitrum Research site
Montpellier, , France
Swedish Orphan Biovitrum Research site
Nancy, , France
Swedish Orphan Biovitrum Research site
Rennes, , France
Swedish Orphan Biovitrum Reserach site
Catanzaro, , Italy
Swedish Orphan Biovitrum Reserach site
Florence, , Italy
Swedish Orphan Biovitrum Research site
Milan, , Italy
Swedish Orphan Biovitrum Reserach site
Naples, , Italy
Swedish Orphan Biovitrum Research Site
Padua, , Italy
Swedish Orphan Biovitrum Reserach site
Palermo, , Italy
Swedish Orphan Biovitrum Reserach site
Parma, , Italy
Swedish Orphan Biovitrum Reserach site
Rome, , Italy
Swedish Orphan Biovitrum Research site
Turin, , Italy
Swedish Orphan Biovitrum Research site
Oslo, , Norway
Swedish Orphan Biovitrum research site
Alicante, , Spain
Swedish Orphan Biovitrum Reserach site
Barcelona, , Spain
Swedish Orphan Biovitrum Reserach site
Madrid, , Spain
Swedish Orphan Biovitrum Research site
Málaga, , Spain
Swedish Orphan Biovitrum Reserach site
Seville, , Spain
Swedish Orphan Biovitrum Research site
Valencia, , Spain
Swedish Orphan Biovitrum Research site
Gothenburg, , Sweden
Swedish Orphan Biovitrum Research site
Malmo, , Sweden
Swedish Orphan Biovitrum Research site
Stockholm, , Sweden
Swedish Orphan Biovitrum Research site
Birmingham, , United Kingdom
Swedish Orphan Biovitrum Research site
Canterbury, , United Kingdom
Swedish Orphan Biovitrum Research site
Liverpool, , United Kingdom
Swedish Orphan Biovitrum Reserach site
London, , United Kingdom
Swedish Orphan Biovitrum Research site
Manchester, , United Kingdom
Swedish Orphan Biovitrum Research site
Sheffield, , United Kingdom
Swedish Orphan Biovitrum Research site
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Oldenburg J, Hay C, Peyvandi F, Lehtinen AE, Pabinger I, Nuesch E, Malmstrom H, Bednar E, Lethagen S. A-SURE: intra-patient comparison of prophylactic effectiveness of a recombinant factor VIII Fc fusion protein versus standard half-life factor VIII in hemophilia A. Hematology. 2025 Dec;30(1):2513186. doi: 10.1080/16078454.2025.2513186. Epub 2025 Jul 4.
Oldenburg J, Hay CRM, Jimenez-Yuste V, Peyvandi F, Schved JF, Szamosi J, Winding B, Lethagen S. Design of a prospective observational study on the effectiveness and real-world usage of recombinant factor VIII Fc (rFVIIIFc) compared with conventional products in haemophilia A: the A-SURE study. BMJ Open. 2019 May 30;9(5):e028012. doi: 10.1136/bmjopen-2018-028012.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Sobi.Elocta-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.