Retrospective Experience Assessing the Real-World Utilization &

Status Completed

Clinical Trial Summary

Retrospective Experience Assessing the Real-World Utilization and Effectiveness of SEVENFACT® [coagulation factor VIIa (recombinant)-jncw] in the USA. The current study will provide a unique opportunity to describe the profile of the early patients selected for treatment with SEVENFACT® and to assess the real-world utilization (effectiveness, safety, tolerability, and modalities of treatment) of SEVENFACT®.

Clinical Trial Description

Parameters collected will include patient socio-demographics, medical history / comorbidities, bleeding disorder history, physical examination, vital signs, prior and concomitant bleeding disorder treatments, bleeding episode / surgery or invasive procedure / prophylaxis details, information on SEVENFACTâ treatment modalities, retrospective investigator rating of SEVENFACTâ effectiveness using the Clinical Global Impression Efficacy Index (CGI-E) and time for bleed control, Adverse Drug Experiences (ADEs) temporally associated with SEVENFACTâ administration, special situations that occurred during SEVENFACTâ administration, whether or not associated with ADE, laboratory testing for activation of the coagulation system or thrombosis, physical examination, and vital signs. ;

Study Design

Related Conditions & MeSH terms

Hemophilia

Clinical Trial Details

NCT number	NCT05904210
Study type	Observational
Source	Laboratoire français de Fractionnement et de Biotechnologies
Contact
Status	Completed
Phase
Start date	November 7, 2023
Completion date	May 31, 2024

View Details

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