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Trial record 1 of 1 for:    sobi alprolix | oslo, Norway
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An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B (B-MORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03901755
Recruitment Status : Active, not recruiting
First Posted : April 3, 2019
Last Update Posted : May 12, 2022
Sponsor:
Information provided by (Responsible Party):
Swedish Orphan Biovitrum

Study Description
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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
Hemophilia B Drug: Alprolix

Study Design
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Study Type : Observational
Actual Enrollment : 151 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A 24-month Prospective, Non-interventional, International, Multicentre Study to Describe the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
Actual Study Start Date : September 12, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Names:
  • 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 Names:
  • Eftrenonacog alfa
  • rFIXFc


Outcome Measures
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Primary Outcome Measures :
  1. Annualised bleeding rate (ABR) [ Time Frame: 24 months ]
    Bleeding episodes assessed according to local practice

  2. Annualised injection frequency [ Time Frame: 24 months ]
    Assessed by prescription

  3. Annualised factor consumption [ Time Frame: 24 months ]
    Assessed by dispensed factor product


Eligibility Criteria
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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.
Criteria

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.

Exclusion Criteria:

  • Participation in an investigational medicinal product trial at enrolment visit
Contacts and Locations
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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): NCT03901755


Locations
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Sponsors and Collaborators
Swedish Orphan Biovitrum
Investigators
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Study Director: Elena Santagostino, MD Swedish Orphan Biovitrum
More Information
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Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT03901755    
Other Study ID Numbers: Sobi.Alprolix-002
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022

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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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Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked