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A chart review study of patients with haemophilia A with inhibitors treated with rFVIIIFc (Elocta®) for immune tolerance induction.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemophili A patients | Patients treated with rFVIIIFc for ITI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rFVIIIFc | Other | Drug according to prescription |
|
| Measure | Description | Time Frame |
|---|---|---|
| ITI with rFVIIIFc: Main dose | Main dose will be assessed on the prescribed dose (IU/kg) | From 2018 to 2022 |
| ITI with rFVIIIFc: Main injection frequency | Main injection frequency will be assessed on the prescribed frequency | From 2018 to 2022 |
| ITI with rFVIIIFc: Duration | Number of treatment months | From 2018 to 2022 |
| ITI with rFVIIIFc: Concomitant by-passing agents | Product name and main dose will be used to describe any concomitant use of by-passing agents. | From 2018 to 2022 |
| Outcome of ITI with rFVIIIFc: Overall outcome | The Investigator will assess overall outcome as: success, partial success, failure, early withdrawal or other. | From 2018 to 2022 |
| Outcome of ITI with rFVIIIFc: Time to undetectable inhibitor titer | Treatment time to reach undetectable inhibitor levels (<0.6 BU/ml) | From 2018 to 2022 |
| Outcome of ITI with rFVIIIFc: Time to normal recovery | Treatment time to reach normal recovery levels (≥66% of the expected value) | From 2018 to 2022 |
| Outcome of ITI with rFVIIIFc: Time to success |
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Inclusion Criteria:
Exclusion Criteria:
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All haemophilia A patients who have been, or who are currently treated with rFVIIIFc for ITI meeting the inclusion and not meeting the exclusion criteria will be invited to participate. Approximately 45 patients from Europe and the Middle East are expected to be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Lethagen | Swedish Orphan Biovitrum | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Orphan Biovitrum Research Site | Paris | France | ||||
| Swedish Orphan Biovitrum Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40289300 | Derived | 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. |
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| ID | Term |
|---|---|
| C587014 | factor VIII-Fc fusion protein |
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Treatment time to reach success (see outcome #5) |
| From 2018 to 2022 |
| Outcome of ITI with rFVIIIFc: Inhibitor titer levels | BU/ml | From 2018 to 2022 |
| Outcome of ITI with rFVIIIFc: Half-life | FVIII half-life (hours) | From 2018 to 2022 |
| Outcome of ITI with rFVIIIFc: Recovery level | FVIII recovery level (%) | From 2018 to 2022 |
| Outcome of ITI with rFVIIIFc: Bleeds | Number of bleeds per month during ITI-treatment | From 2018 to 2022 |
| Long-term outcome after ITI with rFVIIIFc: Occurrence of relapse | Occurrence of relapse (Yes/No) will be assessed by the investigator. | From 2018 to 2022 |
| Long-term outcome after ITI with rFVIIIFc: Time to relapse | Time to occurrence of relapse (see outcome #13) | From 2018 to 2022 |
| Long-term outcome after ITI with rFVIIIFc: Treatment regimen | Treatment regimen will be described as: ITI, prophylaxis or on-demand; and also by product used. | From 2018 to 2022 |
| Long-term outcome after ITI with rFVIIIFc: Bleeds | Number of bleeds per month. | From 2018 to 2022 |
| Rennes |
| France |
| Swedish Orphan Biovitrum Research Site | Tours | France |
| Swedish Orphan Biovitrum Research Site | Frankfurt | Germany |
| Swedish Orphan Biovitrum Research Site | Friedrichshain | Germany |
| Swedish Orphan Biovitrum Research Site | Hanover | Germany |
| Swedish Orphan Biovitrum Research Site | Mitte | Germany |
| Swedish Orphan Biovitrum Research Site | Dublin | Ireland |
| Swedish Orphan Biovitrum Research Site | Catania | Italy |
| Swedish Orphan Biovitrum Research Site | Catanzaro | Italy |
| Swedish Orphan Biovitrum Research Site | Genova | Italy |
| Swedish Orphan Biovitrum Research Site | Naples | Italy |
| Swedish Orphan Biovitrum Research Site | Kuwait City | Kuwait |
| Swedish Orphan Biovitrum Research Site | Oslo | Norway |
| Swedish Orphan Biovitrum Research Site | Riyadh | 12233 | Saudi Arabia |
| Swedish Orphan Biovitrum Research Site (a) | Riyadh | 12713 | Saudi Arabia |
| Swedish Orphan Biovitrum Research Site (p) | Riyadh | 12713 | Saudi Arabia |
| Swedish Orphan Biovitrum Research Site | Bern | Switzerland |