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

Hemophilia Clinical Trial

— SERAPHINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04808349
• Other study ID #: RC21_0053
• Status: Completed
• Start date: July 2, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CH Le Mans	Le Mans
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the effectiveness of turoctocog alfa (NovoEight®) to prevent hemorrhagic complications during minor and major surgery procedures in pwHA	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)	1 year
Secondary	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.	Nature and incidence of AEs, including serious AEs, AEs related to turoctocog alfa (NovoEight®)	1 year
Secondary	Assessing the duration of replacement therapy and factor VIII consumption in clinical practice during surgery in patients treated with turoctocog alfa (NovoEight®)	Number of administrations and total required dose of turoctocog alfa (NovoEight®) in IU/kg	1 year