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
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Have agreed to participate in the observatory after receiving written information on the purpose of the study and the personal data to be collected (agreement of parents for under-age patients);
* Present with haemophilia B and are currently being treated or have previously been treated with Idelvion® as a long-term prophylactic treatment, on-demand treatment or short-term treatment for surgical procedures or to cover periods with a high-risk of bleeding.
* Do not have FIX targeted antibodies at the time of the inclusion visit
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 (known hypersensitivity to FIX or hamster proteins);
* Simultaneous participation in an interventional clinical study on a drug
Primary outcome measure(s)
Annual bleeding rates (overall, spontaneous and traumatic) under the scope of long-term prophylaxis or on-demand treatment of non-surgical bleeding events — Up to 36 months
Number of spontaneous bleeding events per patient — Up to 36 months
Number of Idelvion® infusions and doses injected by infusion required to prevent and resolve non-surgical bleeding episodes — Up to 36 months
Incidence of non-surgical bleeding episodes — Up to 36 months
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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