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A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France (B-SURE)

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ClinicalTrials.gov Identifier: NCT03655340
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Haemophilia B Drug: Alprolix

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France
Actual Study Start Date : September 12, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Prophylactic patients
Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment
Drug: Alprolix
Extended half-life factor IX product
Other Name: Eftrenonacog alfa, rFIXFc

On demand patients
Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for on-demand treatment
Drug: Alprolix
Extended half-life factor IX product
Other Name: Eftrenonacog alfa, rFIXFc




Primary Outcome Measures :
  1. Annualised bleeding rate (ABR) (prophylactic treatment) [ Time Frame: 24 months ]
    Assessed by diary

  2. Annualised injection frequency (prophylactic treatment) [ Time Frame: 24 months ]
    Assessed by diary

  3. Annualised factor consumption (International Unit [IU]) (prophylactic treatment) [ Time Frame: 24 months ]
    Assessed by diary

  4. Amount of factor Product used to treat a bleed (on-demand treatment) [ Time Frame: 24 months ]
    Assessed by diary

  5. Number of injections to treat a bleed (on-demand treatment) [ Time Frame: 24 months ]
    Assessed by diary



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All eligible patients who present for a routine Clinical visit will be asked to participate in the study by the treating physician at participating haemophilia treatment centres in France.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655340


Contacts
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Contact: Clinical Program Leader +46 8 697 2000 sofia.bergenstrale@sobi.com

Locations
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France
Swedish Orphan Biovitrum Research Site Recruiting
Bordeau, France
Swedish Orphan Biovitrum Research Site Recruiting
Caen, France
Swedish Orphan Biovitrum Research Site Recruiting
Clermont-Ferrand, France
Swedish Orphan Biovitrum Research Site Recruiting
Dijon, France
Swedish Orphan Biovitrum Research Site Recruiting
Lille, France
Swedish Orphan Biovitrum Research Site Recruiting
Lyon, France
Swedish Orphan Biovitrum Research Site Recruiting
Marseille, France
Swedish Orphan Biovitrum Research Site Recruiting
Montpellier, France
Swedish Orphan Biovitrum Research Site Recruiting
Nantes, France
Swedish Orphan Biovitrum Research Site Recruiting
Nîmes, France
Swedish Orphan Biovitrum research site Not yet recruiting
Paris, France
Swedish Orphan Biovitrum research site Not yet recruiting
Poitiers, France
Swedish Orphan Biovitrum research site Recruiting
Rennes, France
Swedish Orphan Biovitrum Research Site Recruiting
Rouen, France
Swedish Orphan Biovitrum research site Recruiting
Strasbourg, France
Swedish Orphan Biovitrum Research Site Recruiting
Toulouse, France
Sponsors and Collaborators
Swedish Orphan Biovitrum
Investigators
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Study Director: Erik Brouwer, MD Swedish Orphan Biovitrum

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Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT03655340     History of Changes
Other Study ID Numbers: Sobi.Alprolix-001
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swedish Orphan Biovitrum:
Blood Coagulation Disorder
Hematologic Diseases
Coagulation Protein Disorder
Hemorrhagic Disorder
Genetic Diseases, Inborn

Additional relevant MeSH terms:
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Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hemophilia A
Hemophilia B
Immunoglobulin Fc Fragments
Immunologic Factors
Physiological Effects of Drugs