Clinical and Health-related Outcome of rFVIIIFc Prophylaxis

NCT ID: NCT04583930

Last Updated: 2021-05-11

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

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Recruitment Status

UNKNOWN

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-04-20

Brief Summary

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Current standard therapy for patients with haemophilia (PwH) in the prevention of bleeding episodes is a prophylactic intravenous treatment with recombinant coagulation factor (F) VIII (Haemophilia A) or rather FIX (Haemophilia B) two to three times weekly. With the development of recombinant factor VIII Fc fusion protein (rFVIIIFc) the conventional routine prophylaxis regime is complemented by an extended half-life (EHL) factor replacement prophylaxis with the potential of improved bleed prevention and reduced injection frequency at similar factor consumption. Aim of this longitudinal multicentre study is to evaluate the influence of an EHL factor replacement regime with rFVIIIFc on haemophilic specific parameters (annual bleeding rate, bleeding localisation), joint status, pain, functional parameters, treatment adherence and health-related quality of life in PwH A.

Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Haemophilia A

* Patients suffering from moderate to severe haemophilia A
* Age ≥ 18-years
* Treatment with FVIII prophylaxis
* Submitted written informed consent

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from moderate to severe haemophilia A
* Age ≥ 18-years
* Treatment with FVIII prophylaxis
* Submitted written informed consent

Exclusion Criteria

Patients suffering from other bleeding diseases

* Patients with inhibitors
* Patients without written informed consent
* Age \< 18-year-old
* Any surgeries up to 6 months before the examination date
* Suffering from different rheumatologic diseases like M. Bechterew, Psoriasis or other local or generalized joint infections (Borreliosis, septic arthritis)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Dr. Thomas Hilberg

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Dr. Thomas Hilberg

Head of Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Thomas Hilberg, Prof.

Role: PRINCIPAL_INVESTIGATOR

Head of Department

Locations

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Department of Sports Medicine, University of Wuppertal

Wuppertal, North Rhine-Westphalia, Germany

Site Status RECRUITING

Department of Sports Medicine

Wuppertal, Northwest, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Thomas Hilberg, Prof.

Role: CONTACT

004920237320812

Jamil Hmida

Role: CONTACT

0049202439 ext. 5975

Facility Contacts

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Thomas Hilberg, Prof.

Role: primary

004920237320812

Thomas Hilberg, Prof.

Role: primary

004920237320812

Jamil Hmida

Role: backup

0049202439

Other Identifiers

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Hae-Ger-2019-251-Hil

Identifier Type: -

Identifier Source: org_study_id

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