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Patient-reported Outcomes in Subjects Treated With ReFacto AF Routine Prophylaxis

Hemophilia A Clinical Trial

Official title:
NON-INTERVENTIONAL STUDY TO ASSESS THE HEALTH-RELATED QUALITY OF LIFE IN SEVERE OR MODERATELY SEVERE HEMOPHILIA A SUBJECTS TREATED WITH REFACTO AF ROUTINE PROPHYLAXIS

Clinical Trial Summary

This NIS aims to assess the patient-reported outcomes (PROs) in enrolled subjects

Clinical Trial Description

The design of the study is observational: both prospective and retrospective, national, multicenter, non- interventional. During this observational study, subjects diagnosed with severe or moderately severe (with severe phenotype) hemophilia A receiving routine prophylaxis treatment with ReFacto AF as per local standard clinical care, and in line with local labeling, are to be observed for 12 months. The primary objective is to assess the health-related quality of life in subjects treated with ReFacto AF routine prophylaxis at baseline and after 6 and 12 months. The secondary objectives are: - To assess the subjective physical functioning of subjects treated with ReFacto AF routine prophylaxis at baseline and after 6 and 12 months; - To assess the treatment satisfaction of caregivers of children and subjects above 18 years treated with ReFacto AF routine prophylaxis at baseline and after 6 and 12 months; - To determine in routine clinical practice the mean annualized bleeding rate (ABR) in subjects treated with ReFacto AF routine prophylaxis; - To describe the status of joint health measured by HJHS before and after starting routine prophylaxis for subjects above 18 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02718677
Study type Observational
Source Pfizer
Contact
Status Withdrawn
Phase
Start date September 1, 2019
Completion date January 1, 2022
View Details
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