An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B

Active, not recruiting

• Conditions: Hemophilia B
• Interventions: Drug: Alprolix

• Registration Number: NCT03901755
• Lead Sponsor: Swedish Orphan Biovitrum

Brief Summary

Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic treatment of haemophilia B.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-03
• Study Start: 2019-09-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Have a diagnosis of haemophilia B
• 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 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.

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Exclusion Criteria

• Participation in an investigational medicinal product trial at enrolment visit

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prophylactic patients	Alprolix	Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment
On demand patients	Alprolix	Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for on-demand treatment

Primary Outcome Measures

Name	Time	Method
Annualised bleeding rate (ABR)	24 months	Bleeding episodes assessed according to local practice
Annualised injection frequency	24 months	Assessed by prescription
Annualised factor consumption	24 months	Assessed by dispensed factor product

Trial Locations

Locations (9)

Swedish Orphan Biovitrum Research Site; 🇬🇧 Oxford, United Kingdom

Swedish Orphan Biovitrum Research Site (Haemophilia Center Aghia Sophia Children's Hospital); 🇬🇷 Athens, Greece

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 (Karolinska University Hospital pediatric); 🇸🇪 Stockholm, Sweden

Swedish Orphan Biovitrum Research Site (Hospital Sant Joan de Deu); 🇪🇸 Barcelona, Spain

Swedish Orphan Biovitrum Research Site (Karolinska University Hospital adult); 🇸🇪 Stockholm, Sweden

Swedish Orphan Biovitrum Research Site (Laikο General Hospital of Athens); 🇬🇷 Athens, Greece

Swedish Orphan Biovitrum Research Site (King Faisal Hospital adult); 🇸🇦 Riyadh, Saudi Arabia