Brief Title
Evaluation Of Acceptability And Satisfaction Of Hemophilia Patients Treated With FusENGO
Official Title
Non Interventional Longitudinal Study To Assess The Acceptability And The Satisfaction Of Patients With Haemophilia A Treated Both On Demand And On Prophylaxis With A New Factor Viii Delivery System Fusengo
Brief Summary
This study aims to investigate prospectively throughout a period of 3- 6 months and not to exceed 12 months (according to local therapeutic plans) patients experiences of treatment with Factor VIII in the new device named FuseNGO, a new delivery system for Factor VIII compared to their previous delivery system.
Study Type
Observational
Primary Outcome
Ease of Using Clotting Factor Treatment Score
Secondary Outcome
Number of Participants With Adverse Events and Serious Adverse Events
Condition
Hemophilia A
Intervention
Refacto FusENGO
Study Arms / Comparison Groups
Arm 1: Device
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
86
Start Date
January 27, 2014
Completion Date
December 12, 2016
Primary Completion Date
December 12, 2016
Eligibility Criteria
Inclusion Criteria: - Male adults (aged 18 to 65 years) with Haemophilia A (all severity levels) who currently use FVIII treatment either prophylactically or on-demand using traditional factor VIII delivery mechanisms. - Patients advised for any reason by their physician to switch to a new factor VIII delivery device, namely FuseNGO, before receiving any details about this study or Patients who requested to be treated with a new factor VIII delivery device namely FuseNGO, before receiving any details about this study. Exclusion Criteria: - Patients not previously recommended by their physician to switch to this new factor VIII delivery system or Patients who did not previously ask their physician to be switched to this new factor VIII delivery system. - Patients for which it is anticipated that 10 infusions will not occur in the 12 months following their inclusion in the study.
Gender
Male
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT01959919
Organization ID
B1831081
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
September 2018