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Prospective, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products

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: NCT02976753
Recruitment Status : Active, not recruiting
First Posted : November 29, 2016
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Swedish Orphan Biovitrum

Tracking Information
First Submitted Date November 24, 2016
First Posted Date November 29, 2016
Last Update Posted Date May 13, 2019
Study Start Date October 2016
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 24, 2016)
  • Annualised bleeding rate (ABR) [ Time Frame: 24 months ]
  • Annualised injection frequency [ Time Frame: 24 months ]
  • Annualised factor consumption (International Unit [IU]) [ Time Frame: 24 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02976753 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 Prospective, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products
Official Title 24-month Prospective, Multicentre, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products in the Prophylactic Treatment of Patients With Haemophilia A (A-SURE)
Brief Summary The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia A over a 24-month prospective period. Data will also be collected for a 12 month retrospective period.
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 Probability Sample
Study Population Male patients with a diagnosis of haemophilia A prescribed prophylactic treatment with Elocta or conventional factor product
Condition Hemophilia A
Intervention
  • Drug: efmoroctocog alfa
    extended half-life factor VIII product
    Other Name: Elocta
  • Drug: Factor VIII
    conventional factor VIII product
Study Groups/Cohorts
  • Elocta
    Elocta will be prescribed and administered for prophylactic treatment of patients with haemophilia A according to usual clinical practice
    Intervention: Drug: efmoroctocog alfa
  • Conventional factor VIII product
    Conventional factor VIII products will be prescribed and administered for prophylactic treatment of patients with haemophilia A according to usual clinical practice
    Intervention: Drug: Factor VIII
Publications * Oldenburg J, Hay CRM, Jiménez-Yuste V, Peyvandi F, Schved JF, Szamosi J, Winding B, Lethagen S. Design of a prospective observational study on the effectiveness and real-world usage of recombinant factor VIII Fc (rFVIIIFc) compared with conventional products in haemophilia A: the A-SURE study. BMJ Open. 2019 May 30;9(5):e028012. doi: 10.1136/bmjopen-2018-028012.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 10, 2019)
358
Original Estimated Enrollment
 (submitted: November 24, 2016)
350
Estimated Study Completion Date October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male patients with a diagnosis of haemophilia A
  • Received prophylactic treatment with a factor product for management of haemophilia A in the 12 months prior to enrolment
  • At enrolment prescribed prophylactic treatment with Elocta or conventional factor product regardless of participation in the study
  • Having at least 12 months documented pre-study treatment data regarding prophylactic treatment prescriptions and bleeding episodes prior to the baseline visit
  • 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:

  • Enrolment in a concurrent clinical interventional study involving intake of an investigational medicinal product (IMP), within 1 year prior to enrolment
  • Previously treated with commercially available extended half-life products other than Elocta
  • Presence of factor VIII inhibitors (≥0.60 Bethesda Unit [BU]/mL ) at the latest available inhibitor test using the Nijmegen modified Bethesda assay
Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Belgium,   Finland,   France,   Italy,   Norway,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02976753
Other Study ID Numbers Sobi.Elocta-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Swedish Orphan Biovitrum
Study Sponsor Swedish Orphan Biovitrum
Collaborators Not Provided
Investigators
Study Director: Bent Winding, MD Sweden Orphan Biovitrum
PRS Account Swedish Orphan Biovitrum
Verification Date May 2019