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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 : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Swedish Orphan Biovitrum

Tracking Information
First Submitted Date February 14, 2017
First Posted Date February 16, 2017
Last Update Posted Date April 11, 2019
Actual Study Start Date May 9, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 15, 2017)
  • Annualised bleeding rate (ABR) [ Time Frame: 24 months ]
    Based on bleeding episodes assessed by local practice
  • Annualised injection frequency [ Time Frame: 24 months ]
    Assessed by prescription
  • Annualised factor consumption (IU) [ Time Frame: 24 months ]
    Assessed by dispensed factor product
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03055611 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Haemophilia A
  • Haemophilia B
Intervention
  • Drug: ELOCTA
    Extended half-life factor VIII product
    Other Name: Eloctate, efmoroctocog alfa, rFVIIIFc
  • Drug: ALPROLIX
    Extended half-life factor IX product
    Other Name: Eftrenonacog alfa, rFIXFc
Study Groups/Cohorts
  • Haemophilia A patients
    Elocta will be prescribed according to local practice and administered by patients with haemophilia A for prophylactic treatment
    Intervention: Drug: ELOCTA
  • Haemophilia B patients
    Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment
    Intervention: Drug: ALPROLIX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 15, 2017)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Sofia Bergenstråle +46 8 697 2000 sofia.bergenstrale@sobi.com
Contact: Hanna Jorbrink +46 8 697 2000 hanna.jorbrink@sobi.com
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03055611
Other Study ID Numbers Sobi.HAEM89-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Swedish Orphan Biovitrum
Study Sponsor Swedish Orphan Biovitrum
Collaborators Not Provided
Investigators
Study Director: Bent Winding, MD Swedish Orphan Biovitrum
PRS Account Swedish Orphan Biovitrum
Verification Date April 2019