An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
NCT ID: NCT03901755
Last Updated: 2025-09-29
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
151 participants
OBSERVATIONAL
2019-09-12
2024-03-12
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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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
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Alprolix
Extended half-life factor IX product
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have started Alprolix treatment prior to enrolment visit, or at enrolment prescribed treatment with Alprolix irrespective of participation in the study
* Signed and dated informed consent provided by the patient, or the patients 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
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Swedish Orphan Biovitrum
INDUSTRY
Responsible Party
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Principal Investigators
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Elena Santagostino, MD
Role: STUDY_DIRECTOR
Swedish Orphan Biovitrum
Locations
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Swedish Orphan Biovitrum Research Site
Brno, , Czechia
Swedish Orphan Biovitrum Research Site
Prague, , Czechia
Swedish Orphan Biovitrum Research Site (Haemophilia Center Aghia Sophia Children's Hospital)
Athens, , Greece
Swedish Orphan Biovitrum Research Site (Laikο General Hospital of Athens)
Athens, , Greece
Swedish Orphan Biovitrum Research Site
Dublin, , Ireland
Swedish Orphan Biovitrum Research Site
Bari, , Italy
Swedish Orphan Biovitrum Research Site
Florence, , Italy
Swedish Orphan Biovitrum Research Site
Genova, , Italy
Swedish Orphan Biovitrum Research Site
Milan, , Italy
Swedish Orphan Biovitrum Research Site
Roma, , Italy
Swedish Orphan Biovitrum Research Site
Turin, , Italy
Swedish Orphan Biovitrum Research Site
Oslo, , Norway
Swedish Orphan Biovitrum Research Site (King Faisal Hospital adult)
Riyadh, , Saudi Arabia
Swedish Orphan Biovitrum Research Site (King Faisal Hospital pediatric)
Riyadh, , Saudi Arabia
Swedish Orphan Biovitrum Research Site (Hospital de Vall d'Hebrón)
Barcelona, , Spain
Swedish Orphan Biovitrum Research Site (Hospital Sant Joan de Deu)
Barcelona, , Spain
Swedish Orphan Biovitrum Research Site
Murcia, , Spain
Swedish Orphan Biovitrum Research Site
Vigo, , Spain
Swedish Orphan Biovitrum Research Site
Gothenburg, , Sweden
Swedish Orphan Biovitrum Research Site
Malmo, , Sweden
Swedish Orphan Biovitrum Research Site (Karolinska University Hospital adult)
Stockholm, , Sweden
Swedish Orphan Biovitrum Research Site (Karolinska University Hospital pediatric)
Stockholm, , Sweden
Swedish Orphan Biovitrum Research Site
Hull, , United Kingdom
Swedish Orphan Biovitrum Research Site
London, , United Kingdom
Swedish Orphan Biovitrum Research Site
London, , United Kingdom
Swedish Orphan Biovitrum Research Site
London, , United Kingdom
Swedish Orphan Biovitrum Research Site
London, , United Kingdom
Swedish Orphan Biovitrum Research Site
Manchester, , United Kingdom
Swedish Orphan Biovitrum Research Site
Oxford, , United Kingdom
Countries
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Other Identifiers
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Sobi.Alprolix-002
Identifier Type: -
Identifier Source: org_study_id
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