Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight® for Surgery

Completed

• Conditions: Hemophilia

• Registration Number: NCT04808349
• Lead Sponsor: Nantes University Hospital

Brief Summary

the aim of the SERAPHINE study is to gather data stemming from the French research database BERHLINGO (= Base d'Etude et de Recherche en Hémostase pour Les Investigateurs du Grand-Ouest, i.e. Database for Research on Hemostasis for the Investigators of Western France), in order to get a detailed report about the therapeutic management and use of turoctocog alfa (NovoEight®) in surgery in pwHA (Patient with inherited Hemophilia A).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-22
• Study Start: 2021-07-02
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-23
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male or female
• Regardless of age
• No inhibitor (anti-FVIII alloantibodies) at the time of treatment.
• No objections expressed to participate in the study after having been informed of its purposes and the data involved.
• No other inherited hemorrhagic disorders than HA

Exclusion Criteria

In order to reflect the reality of daily practice, no criteria for non-inclusion are provided for other than the refusal of the patient or his or her legal representative to participate in the study or the existence in the patient of a contraindication to the use of turoctocog alfa (NovoEight®) treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessing the effectiveness of turoctocog alfa (NovoEight®) to prevent hemorrhagic complications during minor and major surgery procedures in pwHA	1 year	Overall evaluation by the investigator of the hemostatic effectiveness of turoctocog alfa (NovoEight®) for the prevention of hemorrhagic complications in a surgical setting (excellent, good, fair, poor/none according to recommendations of the SSC of ISTH)

Secondary Outcome Measures

Name	Time	Method
Assessing the safety of turoctocog alfa (NovoEight®) when used during surgery in patients with the occurrence of adverse events (AEs), especially hemorrhagic and thrombotic complications or development of inhibitors.	1 year	Nature and incidence of AEs, including serious AEs, AEs related to turoctocog alfa (NovoEight®)
Assessing the duration of replacement therapy and factor VIII consumption in clinical practice during surgery in patients treated with turoctocog alfa (NovoEight®)	1 year	Number of administrations and total required dose of turoctocog alfa (NovoEight®) in IU/kg

Trial Locations

Locations (3)

CH Le Mans; 🇫🇷 Le Mans, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU Angers; 🇫🇷 Angers, France