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Evaluation Of Acceptability And Satisfaction Of Hemophilia Patients Treated With FusENGO

Pfizer logo

Pfizer

Status

Completed

Conditions

Hemophilia A

Treatments

Device: Refacto FusENGO

Study type

Observational

Funder types

Industry

Identifiers

NCT01959919
B1831081

Details and patient eligibility

About

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.

Enrollment

86 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

86 participants in 1 patient group

Arm 1: Device
Treatment:
Device: Refacto FusENGO

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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