Evaluation Of Acceptability And Satisfaction Of Hemophilia Patients Treated With FusENGO

NCT01959919

Last updated date
Study Location
Istituto di Ematologia
Roma, Lazio, 00161, Italy
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Approximately 200 patients with Hemophilia A (all severity levels) will be enrolled in approximately 20 centers in Italy.
Condition Hemophilia A
Intervention Device: Refacto FusENGO
Dosage will be chosen by PI based on patient condition.
Study Groups/Cohorts Arm 1: Device
Intervention: Device: Refacto FusENGO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 24, 2018)
86
Original Estimated Enrollment
 (submitted: October 9, 2013)
200
Actual Study Completion Date December 12, 2016
Actual Primary Completion Date December 12, 2016   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01959919
Other Study ID Numbers B1831081
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2018