A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France
NCT ID: NCT03655340
Last Updated: 2024-09-19
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
91 participants
OBSERVATIONAL
2018-09-12
2022-03-16
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.
An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
NCT03901755
A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
NCT03055611
Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B
NCT01233440
A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
NCT01496274
A Safety and Efficacy Study of a Recombinant Factor IX in Patients With Severe Hemophilia B
NCT01361126
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.
Prophylactic patients
Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment
Alprolix
Extended half-life factor IX product
On demand patients
Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for on-demand treatment
Alprolix
Extended half-life factor IX product
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Alprolix
Extended half-life factor IX 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
* Have started Alprolix treatment prior to enrolment visit, or at enrolment prescribed treatment with Alprolix, regardless of participation in the study
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
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.
Elena Santagostino, MD
Role: STUDY_DIRECTOR
Swedish Orphan Biovitrum
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Swedish Orphan Biovitrum Research Site (CHU de Bordeaux)
Bordeaux, , France
Swedish Orphan Biovitrum Research Site
Brest, , France
Swedish Orphan Biovitrum Research Site
Caen, , France
Swedish Orphan Biovitrum Research Site
Chambéry, , France
Swedish Orphan Biovitrum Research Site
Clermont-Ferrand, , France
Swedish Orphan Biovitrum Research Site
Dijon, , France
Swedish Orphan Biovitrum Research Site
La Réunion, , France
Swedish Orphan Biovitrum Research Site
Lille, , France
Swedish Orphan Biovitrum Research Site
Marseille, , France
Swedish Orphan Biovitrum Research Site
Montpellier, , France
Swedish Orphan Biovitrum Research Site
Nantes, , France
Swedish Orphan Biovitrum Research Site
Nîmes, , France
Swedish Orphan Biovitrum research site
Paris, , France
Swedish Orphan Biovitrum research site
Poitiers, , France
Swedish Orphan Biovitrum research site
Rennes, , France
Swedish Orphan Biovitrum Research Site
Rouen, , France
Swedish Orphan Biovitrum research site
Strasbourg, , France
Swedish Orphan Biovitrum Research Site
Toulouse, , France
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.
Chambost H, Repesse Y, Genre-Volot F, Desprez D, Castet SM, Vanderbecken S, Zidi M, Gandossi C, Nuesch E, Palmborg H, Santagostino E; B-SURE Study Group. Real-world usage and effectiveness of recombinant factor IX Fc in haemophilia B from the B-SURE study in France. Ther Adv Hematol. 2025 Jan 26;16:20406207241311535. doi: 10.1177/20406207241311535. eCollection 2025.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Sobi.Alprolix-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.