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Completed

NCT Number: NCT03951103

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

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

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Key information

Conditions

Hemophilia A With Inhibitor

Sex eligibility

All sexes

Study type

Observational

Primary location

Swedish Orphan Biovitrum Research Site, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rFVIIIFc

Other

Drug according to prescription

Other names: Elocta

Primary outcomes

  1. ITI with rFVIIIFc: Main dose

    Time frame: From 2018 to 2022

    Main dose will be assessed on the prescribed dose (IU/kg)

  2. ITI with rFVIIIFc: Main injection frequency

    Time frame: From 2018 to 2022

    Main injection frequency will be assessed on the prescribed frequency

  3. ITI with rFVIIIFc: Duration

    Time frame: From 2018 to 2022

    Number of treatment months

  4. ITI with rFVIIIFc: Concomitant by-passing agents

    Time frame: From 2018 to 2022

    Product name and main dose will be used to describe any concomitant use of by-passing agents.

  5. Outcome of ITI with rFVIIIFc: Overall outcome

    Time frame: From 2018 to 2022

    The Investigator will assess overall outcome as: success, partial success, failure, early withdrawal or other.

  6. Outcome of ITI with rFVIIIFc: Time to undetectable inhibitor titer

    Time frame: From 2018 to 2022

    Treatment time to reach undetectable inhibitor levels (<0.6 BU/ml)

  7. Outcome of ITI with rFVIIIFc: Time to normal recovery

    Time frame: From 2018 to 2022

    Treatment time to reach normal recovery levels (≥66% of the expected value)

  8. Outcome of ITI with rFVIIIFc: Time to success

    Time frame: From 2018 to 2022

    Treatment time to reach success (see outcome #5)

  9. Outcome of ITI with rFVIIIFc: Inhibitor titer levels

    Time frame: From 2018 to 2022

    BU/ml

  10. Outcome of ITI with rFVIIIFc: Half-life

    Time frame: From 2018 to 2022

    FVIII half-life (hours)

  11. Outcome of ITI with rFVIIIFc: Recovery level

    Time frame: From 2018 to 2022

    FVIII recovery level (%)

  12. Outcome of ITI with rFVIIIFc: Bleeds

    Time frame: From 2018 to 2022

    Number of bleeds per month during ITI-treatment

  13. Long-term outcome after ITI with rFVIIIFc: Occurrence of relapse

    Time frame: From 2018 to 2022

    Occurrence of relapse (Yes/No) will be assessed by the investigator.

  14. Long-term outcome after ITI with rFVIIIFc: Time to relapse

    Time frame: From 2018 to 2022

    Time to occurrence of relapse (see outcome #13)

  15. Long-term outcome after ITI with rFVIIIFc: Treatment regimen

    Time frame: From 2018 to 2022

    Treatment regimen will be described as: ITI, prophylaxis or on-demand; and also by product used.

  16. Long-term outcome after ITI with rFVIIIFc: Bleeds

    Time frame: From 2018 to 2022

    Number of bleeds per month.

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 15, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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