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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03655340
Other study ID # Sobi.Alprolix-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 12, 2018
Est. completion date March 16, 2022

Study information

Verified date January 2024
Source Swedish Orphan Biovitrum
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date March 16, 2022
Est. primary completion date March 16, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Have a diagnosis of haemophilia B and been treated previously with factor IX Product - 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: - Participation in an investigational medicinal product trial at enrolment visit

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Alprolix
Extended half-life factor IX product

Locations

Country Name City State
France 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

Sponsors (2)

Lead Sponsor Collaborator
Swedish Orphan Biovitrum Cerner Enviza

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Annualised bleeding rate (ABR) (prophylactic treatment) Assessed by diary 24 months
Primary Annualised injection frequency (prophylactic treatment) Assessed by diary 24 months
Primary Annualised factor consumption (International Unit [IU]) (prophylactic treatment) Assessed by diary 24 months
Primary Amount of factor Product used to treat a bleed (on-demand treatment) Assessed by diary 24 months
Primary Number of injections to treat a bleed (on-demand treatment) Assessed by diary 24 months
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