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Completed

NCT Number: NCT02976753

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

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Sex eligibility

Male

Study type

Observational

Primary location

Swedish Orphan Biovitrum Research site, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

efmoroctocog alfa

Drug

extended half-life factor VIII product

Other names: Elocta

factor VIII

Drug

conventional factor VIII product

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Collaborators

  • ICON plc

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Nov 29, 2016
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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