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rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A

NCT ID: NCT03951103

Last Updated: 2024-09-19

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

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-07

Study Completion Date

2022-09-30

Brief Summary

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A chart review study of patients with haemophilia A with inhibitors treated with rFVIIIFc (Elocta®) for immune tolerance induction.

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Detailed Description

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A multicenter, international, non- interventional, retrospective and prospective medical chart review study. Data will be collected from medical records for patients diagnosed with haemophilia A who have been, or who are currently, treated with rFVIIIFc for ITI . The study will be descriptive in nature and report on baseline characteristics, treatment and outcomes for patients who have been, or who are currently, treated with rFVIIIFc for ITI.

Conditions

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Hemophilia A With Inhibitor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Hemophili A patients

Patients treated with rFVIIIFc for ITI

rFVIIIFc

Intervention Type OTHER

Drug according to prescription

Interventions

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rFVIIIFc

Drug according to prescription

Intervention Type OTHER

Other Intervention Names

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Elocta

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with haemophilia A who have been, or who are currently, treated with rFVIIIFc for ITI.
* 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 data collection are undertaken. Assent should be obtained from paediatric patients according to local regulations.

Exclusion Criteria

* Current participation in any investigational medicinal product trial.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Lethagen

Role: STUDY_DIRECTOR

Swedish Orphan Biovitrum

Locations

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Swedish Orphan Biovitrum Research Site

Paris, , France

Site Status

Swedish Orphan Biovitrum Research Site

Rennes, , France

Site Status

Swedish Orphan Biovitrum Research Site

Tours, , France

Site Status

Swedish Orphan Biovitrum Research Site

Frankfurt, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

Friedrichshain, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

Hanover, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

Mitte, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

Dublin, , Ireland

Site Status

Swedish Orphan Biovitrum Research Site

Catania, , Italy

Site Status

Swedish Orphan Biovitrum Research Site

Catanzaro, , Italy

Site Status

Swedish Orphan Biovitrum Research Site

Genova, , Italy

Site Status

Swedish Orphan Biovitrum Research Site

Napoli, , Italy

Site Status

Swedish Orphan Biovitrum Research Site

Kuwait City, , Kuwait

Site Status

Swedish Orphan Biovitrum Research Site

Oslo, , Norway

Site Status

Swedish Orphan Biovitrum Research Site

Riyadh, , Saudi Arabia

Site Status

Swedish Orphan Biovitrum Research Site (a)

Riyadh, , Saudi Arabia

Site Status

Swedish Orphan Biovitrum Research Site (p)

Riyadh, , Saudi Arabia

Site Status

Swedish Orphan Biovitrum Research Site

Bern, , Switzerland

Site Status

Countries

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France Germany Ireland Italy Kuwait Norway Saudi Arabia Switzerland

References

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Klamroth R, Al Saleh M, Glosli H, Schiavulli M, Guillet B, Bystricka L, Schonstein A, Lethagen S. Immune Tolerance Induction With a Recombinant Factor VIII Fc in Haemophilia A: Data From a Chart Review Study. Eur J Haematol. 2025 Aug;115(2):134-141. doi: 10.1111/ejh.14427. Epub 2025 Apr 27.

Reference Type DERIVED
PMID: 40289300 (View on PubMed)

Other Identifiers

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Sobi.Elocta-004

Identifier Type: -

Identifier Source: org_study_id

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