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

Study Overview
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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.

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.

Official Title
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A Chart Review Study of Patients With Haemophilia A With Inhibitors Treated With rFVIIIFc (Elocta®) for Immune Tolerance Induction

Conditions
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Hemophilia A With Inhibitor

Intervention / Treatment
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* Other: rFVIIIFc


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemophili A patients<br>Patients treated with rFVIIIFc for ITI | Other: rFVIIIFc<br>* Drug according to prescription<br>* Other names: Elocta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elocta, rFVIIIFc