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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02976753

Enrollment

361

Registered

2016-11-29

Start date

2016-12-31

Completion date

2021-11-03

Last updated

2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

Blood Coagulation Disorders, Hematologic Diseases, Coagulation Protein Disorders, Hemorrhagic Disorders, Genetic Diseases, Inborn

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.

Interventions

DRUGefmoroctocog alfa

extended half-life factor VIII product

DRUGFactor VIII

conventional factor VIII product

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Austria, Belgium, Finland, France, Italy, Norway, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026