A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B

Completed

• Conditions: Haemophilia A; Haemophilia B
• Interventions: Drug: ELOCTA; Drug: ALPROLIX

• Registration Number: NCT03055611
• Lead Sponsor: Swedish Orphan Biovitrum

Brief Summary

Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in the prophylactic treatment of haemophilia A and B.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-16
• Study Start: 2017-05-09
• Primary Completion: 2022-04-19
• Study Completion: 2022-04-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• Have a diagnosis of haemophilia A or B and previously treated with factor Product
• Have started prophylactic Elocta/Alprolix treatment prior to enrollment visit, or at enrollment prescribed prophylactic treatment with Elocta or Alprolix regardless of participation in the study
• 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.

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Exclusion Criteria

• Participation in an investigational medicinal product trial, from four weeks prior to first injection with Elocta or Alprolix to enrollment visit.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Haemophilia A patients	ELOCTA	Elocta will be prescribed according to local practice and administered by patients with haemophilia A for prophylactic treatment
Haemophilia B patients	ALPROLIX	Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment

Primary Outcome Measures

Name	Time	Method
Annualised bleeding rate (ABR)	24 months	Based on bleeding episodes assessed by local practice
Annualised factor consumption (IU)	24 months	Assessed by dispensed factor product
Annualised injection frequency	24 months	Assessed by prescription

Trial Locations

Locations (3)

Swedish Orphan Biovitrum Reserach site; 🇩🇪 Münster, Germany

Swedish Orphan Biovitrum Reserach Site; 🇩🇪 Mörfelden-Walldorf, Germany

Swedish Orphan Biovitrum Research Site; 🇩🇪 Würzburg, Germany