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

October 1, 2024 updated by: Swedish Orphan Biovitrum

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

361

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Swedish Orphan Biovitrum Research site
      • Linz, Austria
        • Swedish Orphan Biovitrum Research site
      • St Polten, Austria
        • Swedish Orphan Biovitrum Research site
      • Vienna, Austria
        • Swedish Orphan Biovitrum Research site
  • Belgium
      • Brussel, Belgium
        • Swedish Orphan Biovitrum Research site
  • Finland
      • Helsinki, Finland
        • Swedish Orphan Biovitrum Research site
  • France
      • Caen, France
        • Swedish Orphan Biovitrum Research site
      • Montpellier, France
        • Swedish Orphan Biovitrum Research site
      • Nancy, France
        • Swedish Orphan Biovitrum Research site
      • Rennes, France
        • Swedish Orphan Biovitrum Research site
  • Italy
      • Catanzaro, Italy
        • Swedish Orphan Biovitrum Reserach site
      • Florence, Italy
        • Swedish Orphan Biovitrum Reserach site
      • Milano, Italy
        • Swedish Orphan Biovitrum Research site
      • Naples, Italy
        • Swedish Orphan Biovitrum Reserach site
      • Padova, Italy
        • Swedish Orphan Biovitrum Research site
      • Palermo, Italy
        • Swedish Orphan Biovitrum Reserach site
      • Parma, Italy
        • Swedish Orphan Biovitrum Reserach site
      • Rome, Italy
        • Swedish Orphan Biovitrum Reserach site
      • Turin, Italy
        • Swedish Orphan Biovitrum Research site
  • Norway
      • Oslo, Norway
        • Swedish Orphan Biovitrum Research site
  • Spain
      • Alicante, Spain
        • Swedish Orphan Biovitrum Research site
      • Barcelona, Spain
        • Swedish Orphan Biovitrum Reserach site
      • Madrid, Spain
        • Swedish Orphan Biovitrum Reserach site
      • Málaga, Spain
        • Swedish Orphan Biovitrum Research site
      • Sevilla, Spain
        • Swedish Orphan Biovitrum Reserach site
      • Valencia, Spain
        • Swedish Orphan Biovitrum Research site
  • Sweden
      • Göteborg, Sweden
        • Swedish Orphan Biovitrum Research site
      • Malmö, Sweden
        • Swedish Orphan Biovitrum Research site
      • Stockholm, Sweden
        • Swedish Orphan Biovitrum Research site
  • United Kingdom
      • Birmingham, United Kingdom
        • Swedish Orphan Biovitrum Research site
      • Canterbury, United Kingdom
        • Swedish Orphan Biovitrum Research site
      • Liverpool, United Kingdom
        • Swedish Orphan Biovitrum Research site
      • London, United Kingdom
        • Swedish Orphan Biovitrum Reserach site
      • Manchester, United Kingdom
        • Swedish Orphan Biovitrum Research site
      • Sheffield, United Kingdom
        • Swedish Orphan Biovitrum Research site
      • Southampton, United Kingdom
        • Swedish Orphan Biovitrum Research site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annualised bleeding rate (ABR)
Time Frame: 24 months
24 months
Annualised injection frequency
Time Frame: 24 months
24 months
Annualised factor consumption (International Unit [IU])
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish Orphan Biovitrum

Collaborators

ICON plc

Investigators

  • Study Director: Study Physician, MD, Sweden Orphan Biovitrum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

November 3, 2021

Study Completion (Actual)

November 3, 2021

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria

November 24, 2016

First Posted (Estimated)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sobi.Elocta-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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