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

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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

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.

Condition or disease Intervention/treatment
Hemophilia A Drug: efmoroctocog alfa Drug: Factor VIII

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Study Type : Observational
Actual Enrollment : 358 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : October 2016
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021


Group/Cohort Intervention/treatment
Elocta
Elocta will be prescribed and administered for prophylactic treatment of patients with haemophilia A according to usual clinical practice
Drug: efmoroctocog alfa
extended half-life factor VIII product
Other Name: Elocta

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
Drug: Factor VIII
conventional factor VIII product




Primary Outcome Measures :
  1. Annualised bleeding rate (ABR) [ Time Frame: 24 months ]
  2. Annualised injection frequency [ Time Frame: 24 months ]
  3. Annualised factor consumption (International Unit [IU]) [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male patients with a diagnosis of haemophilia A prescribed prophylactic treatment with Elocta or conventional factor product
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

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): NCT02976753


  Hide Study Locations
Locations
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Austria
Swedish Orphan Biovitrum Research site
Innsbruck, Austria
Swedish Orphan Biovitrum Research site
Linz, Austria
Swedish Orphan Biovitrum Research Site
St Polten, Austria
Swedish Orphan Biovitrum Research site
Vienna, Austria
Belgium
Swedish Orphan Biovitrum Research site
Brussel, Belgium
Finland
Swedish Orphan Biovitrum Research site
Helsinki, Finland
France
Swedish Orphan Biovitrum Research site
Caen, France
Swedish Orphan Biovitrum Research site
Montpellier, France
Swedish Orphan Biovitrum Research site
Nancy, France
Swedish Orphan Biovitrum Research site
Rennes, France
Italy
Swedish Orphan Biovitrum Reserach site
Catanzaro, Italy
Swedish Orphan Biovitrum Reserach site
Florence, Italy
Swedish Orphan Biovitrum Research site
Milano, Italy
Swedish Orphan Biovitrum Reserach site
Naples, Italy
Swedish Orphan Biovitrum Research Site
Padova, Italy
Swedish Orphan Biovitrum Reserach site
Palermo, Italy
Swedish Orphan Biovitrum Reserach site
Parma, Italy
Swedish Orphan Biovitrum Reserach site
Rome, Italy
Swedish Orphan Biovitrum Research site
Turin, Italy
Norway
Swedish Orphan Biovitrum Research site
Oslo, Norway
Spain
Swedish Orphan Biovitrum research site
Alicante, Spain
Swedish Orphan Biovitrum Reserach site
Barcelona, Spain
Swedish Orphan Biovitrum Reserach site
Madrid, Spain
Swedish Orphan Biovitrum Research site
Málaga, Spain
Swedish Orphan Biovitrum Reserach site
Sevilla, Spain
Swedish Orphan Biovitrum Research site
Valencia, Spain
Sweden
Swedish Orphan Biovitrum Research site
Göteborg, Sweden
Swedish Orphan Biovitrum Research site
Malmö, Sweden
Swedish Orphan Biovitrum Research site
Stockholm, Sweden
United Kingdom
Swedish Orphan Biovitrum Research site
Birmingham, United Kingdom
Swedish Orphan Biovitrum Research site
Canterbury, United Kingdom
Swedish Orphan Biovitrum Research site
Liverpool, United Kingdom
Swedish Orphan Biovitrum Reserach site
London, United Kingdom
Swedish Orphan Biovitrum Research site
Manchester, United Kingdom
Swedish Orphan Biovitrum Research site
Sheffield, United Kingdom
Swedish Orphan Biovitrum Research site
Southampton, United Kingdom
Sponsors and Collaborators
Swedish Orphan Biovitrum
Investigators
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Study Director: Bent Winding, MD Sweden Orphan Biovitrum

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT02976753     History of Changes
Other Study ID Numbers: Sobi.Elocta-002
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants