Observatory of Patients With Haemophilia B Treated by IdElvion®

Last updated: January 7, 2025
Sponsor: CSL Behring
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hemophilia

Treatment

N/A

Clinical Study ID

NCT05086575
OrPHEe study
2021-A00468-33
  • All Genders

Study Summary

OrPHEe is a non-interventional, prospective and national study which aim is to record real life data in haemophilia B French patients treated with Idelvion® to confirm the efficacy and safety of this product established in clinical development studies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have agreed to participate in the observatory after receiving written information onthe purpose of the study and the personal data to be collected (agreement of parentsfor under-age patients);

  • Present with haemophilia B and are currently being treated or have previously beentreated with Idelvion® as a long-term prophylactic treatment, on-demand treatment orshort-term treatment for surgical procedures or to cover periods with a high-risk ofbleeding.

  • Do not have FIX targeted antibodies at the time of the inclusion visit

Exclusion

Exclusion Criteria:

  • Refusal by the patient or his/her legal representative to participate in the study;

  • Existence of a contraindication to the use of Idelvion® treatment (knownhypersensitivity to FIX or hamster proteins);

  • Simultaneous participation in an interventional clinical study on a drug

Study Design

Total Participants: 222
Study Start date:
December 03, 2021
Estimated Completion Date:
December 31, 2027

Study Description

Haemophilia B is a congenital coagulation disorder caused by a deficiency or anomaly of coagulation factor IX (FIX).

The severity of the haemophilia depends on the extent of the FIX deficiency with clinical manifestations differing depending on the location of the bleed.

Treatment of this disease involves the administration of the deficient factor, i.e. FIX, to patients. Depending on the severity of the disease and context, a range of treatment regimens are available (long-term prophylactic treatment for the prevention of non-surgical bleeds, short-term prophylactic treatment for high-risk periods, treatment for the prevention of surgical bleeds or on-demand curative treatment).

CSL Behring has developed a long-acting recombinant FIX, i.e. rIX-FP (Idelvion®), to extend the intervals between the administrations of treatment while also providing a therapeutic benefit. Data from clinical studies clearly confirm the therapeutic benefit of Idelvion® in adult and paediatric patients with haemophilia B previously receiving an on-demand treatment for bleeding episodes, for long-term prophylaxis, as well as in patients undergoing surgery.

Connect with a study center

  • CHU Amiens - Picardie

    Amiens,
    France

    Site Not Available

  • CH Annecy Genevois

    Annecy,
    France

    Site Not Available

  • CHRU Besançon

    Besançon,
    France

    Site Not Available

  • CHU Bordeaux - Hôpital Pellegrin

    Bordeaux,
    France

    Site Not Available

  • CHRU Brest

    Brest,
    France

    Site Not Available

  • CHU Caen

    Caen,
    France

    Site Not Available

  • CHU Clermont-Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • CHU Dijon

    Dijon,
    France

    Site Not Available

  • Hôpital Simone Veil

    Eaubonne,
    France

    Site Not Available

  • CHU de Grenoble

    Grenoble,
    France

    Site Not Available

  • CRC-MHC Hôpital Kremlin Bicêtre

    Le Kremlin-Bicêtre,
    France

    Site Not Available

  • CH du Mans

    Le Mans,
    France

    Site Not Available

  • CHRU Lille

    Lille,
    France

    Site Not Available

  • CHU de Limoges

    Limoges,
    France

    Site Not Available

  • Hôpital Edouard Herriot

    Lyon,
    France

    Site Not Available

  • CHU Montpellier

    Montpellier,
    France

    Site Not Available

  • CHRU Nancy

    Nancy,
    France

    Site Not Available

  • CHRU Nancy

    Nangis,
    France

    Site Not Available

  • CHU Nantes

    Nantes,
    France

    Site Not Available

  • CHU Nice

    Nice,
    France

    Site Not Available

  • Hôpital Necker Enfants Malades

    Paris,
    France

    Site Not Available

  • CHU de Reims

    Reims,
    France

    Site Not Available

  • CHU Rennes

    Rennes,
    France

    Site Not Available

  • CHU Rouen

    Rouen,
    France

    Site Not Available

  • CHU Saint-Etienne

    Saint-Étienne,
    France

    Site Not Available

  • CHRU Strasbourg

    Strasbourg,
    France

    Site Not Available

  • CHU Toulouse

    Toulouse, 31059
    France

    Site Not Available

  • CHU Tours

    Tours,
    France

    Site Not Available

  • Hôpital André Mignot - CH Versailles

    Versailles,
    France

    Site Not Available

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