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

NCT ID: NCT03055611

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-09

Study Completion Date

2022-04-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Haemophilia A Haemophilia B

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Haemophilia A patients

Elocta will be prescribed according to local practice and administered by patients with haemophilia A for prophylactic treatment

ELOCTA

Intervention Type DRUG

Extended half-life factor VIII product

Haemophilia B patients

Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment

ALPROLIX

Intervention Type DRUG

Extended half-life factor IX product

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ELOCTA

Extended half-life factor VIII product

Intervention Type DRUG

ALPROLIX

Extended half-life factor IX product

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Eloctate, efmoroctocog alfa, rFVIIIFc Eftrenonacog alfa, rFIXFc

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Study Physician, MD

Role: STUDY_DIRECTOR

Swedish Orphan Biovitrum

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Swedish Orphan Biovitrum Reserach site

Berlin, , Germany

Site Status

Swedish Orphan Biovitrum Reserach Site

Blaubeuren Abbey, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

Bonn, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

Delmenhorst, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

Duisburg, , Germany

Site Status

Swedish Orphan Biovitrum Reserach site

Erlangen, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

Frankfurt, , Germany

Site Status

Swedish Orphan Biovitrum Reserach site

Frankfurt, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

Fürth, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

Hamburg, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

Hanover, , Germany

Site Status

Swedish Orphan Biovitrum Reserach site

Hanover, , Germany

Site Status

Swedish Orphan Biovitrum Reserach site

Heidelberg, , Germany

Site Status

Swedish Orphan Biovitrum Reserach site

Homburg, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

Jena, , Germany

Site Status

Swedish Orphan Biovitrum Reserach Site

Jena, , Germany

Site Status

Swedish Orphan Biovitrum Reserach site

Leipzig, , Germany

Site Status

Swedish Orphan Biovitrum Reserach Site

Mörfelden-Walldorf, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

München, , Germany

Site Status

Swedish Orphan Biovitrum Reserach site

München, , Germany

Site Status

Swedish Orphan Biovitrum Reserach site

Münster, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

Würzburg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Sobi.HAEM89-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Hemophilia Inhibitor Prevention Trial
NCT04303559 TERMINATED PHASE3