Observatory of Patients With Haemophilia B Treated by IdElvion® (OrPHEe)

NCT05086575 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	CSL Behring
Status	ACTIVE_NOT_RECRUITING
Enrolment	222
Start date	2021-12-03
Completion	2027-12

Conditions

• Haemophilia B

Primary outcomes

• 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

Countries

France