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Trial record 1 of 10 for:    ALPROLIX
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A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B (PREVENT)

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ClinicalTrials.gov Identifier: NCT03055611
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in the prophylactic treatment of haemophilia A and B.

Condition or disease Intervention/treatment
Haemophilia A Haemophilia B Drug: ELOCTA Drug: ALPROLIX

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-World Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
Actual Study Start Date : May 9, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Haemophilia A patients
Elocta will be prescribed according to local practice and administered by patients with haemophilia A for prophylactic treatment
Drug: ELOCTA
Extended half-life factor VIII product
Other Name: Eloctate, efmoroctocog alfa, rFVIIIFc
Haemophilia B 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


Outcome Measures

Primary Outcome Measures :
  1. Annualised bleeding rate (ABR) [ Time Frame: 24 months ]
    Based on bleeding episodes assessed by local practice

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

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All eligible Elocta and Alprolix 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 Germany.
Criteria

Inclusion Criteria:

  • Have a diagnosis of haemophilia A or B and previously treated with factor Product
  • Have started prophylactic Elocta/Alprolix treatment prior to enrollment visit, or at enrollment prescribed prophylactic treatment with Elocta or 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, from four weeks prior to first injection with Elocta or Alprolix to enrollment visit.
Contacts and Locations

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): NCT03055611


Contacts
Contact: Michael O'Malley +46 8 697 2000 michael.omalley@sobi.com
Contact: Sofia Bergenstråle +46 8 697 2000 sofia.bergenstrale@sobi.com

Locations
Germany
Swedish Orphan Biovitrum Reserach site Recruiting
Bad Homburg vor der Höhe, Germany
Swedish Orphan Biovitrum Reserach site Not yet recruiting
Berlin, Germany
Swedish Orphan Biovitrum Research Site Not yet recruiting
Bonn, Germany
Swedish Orphan Biovitrum Reserach site Not yet recruiting
Braunschweig, Germany
Swedish Orphan Biovitrum Research Site Not yet recruiting
Delmenhorst, Germany
Swedish Orphan Biovitrum Research Site Not yet recruiting
Duisburg, Germany
Swedish Orphan Biovitrum Reserach site Not yet recruiting
Erlangen, Germany
Swedish Orphan Biovitrum Research Site Not yet recruiting
Frankfurt, Germany
Swedish Orphan Biovitrum Reserach site Not yet recruiting
Frankfurt, Germany
Swedish Orphan Biovitrum Research Site Not yet recruiting
Fürth, Germany
Swedish Orphan Biovitrum Research Site Not yet recruiting
Hamburg, Germany
Swedish Orphan Biovitrum Research Site Not yet recruiting
Hannover, Germany
Swedish Orphan Biovitrum Reserach site Recruiting
Hannover, Germany
Swedish Orphan Biovitrum Reserach site Recruiting
Heidelberg, Germany
Swedish Orphan Biovitrum Reserach site Not yet recruiting
Homburg, Germany
Swedish Orphan Biovitrum Research Site Not yet recruiting
Jena, Germany
Swedish Orphan Biovitrum Reserach Site Not yet recruiting
Jena, Germany
Swedish Orphan Biovitrum Reserach site Recruiting
Leipzig, Germany
Swedish Orphan Biovitrum Research Site Not yet recruiting
München, Germany
Swedish Orphan Biovitrum Reserach site Not yet recruiting
München, Germany
Swedish Orphan Biovitrum Reserach site Recruiting
Münster, Germany
Swedish Orphan Biovitrum Research Site Not yet recruiting
Stuttgart, Germany
Swedish Orphan Biovitrum Reserach site Recruiting
Wiesbaden, Germany
Swedish Orphan Biovitrum Research Site Not yet recruiting
Würzburg, Germany
Sponsors and Collaborators
Swedish Orphan Biovitrum
Investigators
Study Director: Bent Winding, MD Swedish Orphan Biovitrum
More Information

Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT03055611     History of Changes
Other Study ID Numbers: Sobi.HAEM89-002
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

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

Additional relevant MeSH terms:
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
Factor VIII
Coagulants