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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)

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: NCT03055611
Recruitment Status : Active, not recruiting
First Posted : February 16, 2017
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Swedish Orphan Biovitrum

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

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Study Type : Observational
Actual Enrollment : 198 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 : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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.

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


Locations
Show Show 22 study locations
Sponsors and Collaborators
Swedish Orphan Biovitrum
Investigators
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Study Director: Elena Santagostino, MD Swedish Orphan Biovitrum
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Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT03055611    
Other Study ID Numbers: Sobi.HAEM89-002
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
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