Trials / Withdrawn
WithdrawnNCT02718677
Patient-reported Outcomes in Subjects Treated With ReFacto AF Routine Prophylaxis
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
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Male
- Age
- 2 Years – 30 Years
- Healthy volunteers
- Not accepted
Summary
This NIS aims to assess the patient-reported outcomes (PROs) in enrolled subjects
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Refacto AF | Observational - Non-Interventional Study |
Timeline
- Start date
- 2019-09-01
- Primary completion
- 2021-05-01
- Completion
- 2022-01-01
- First posted
- 2016-03-24
- Last updated
- 2020-11-16
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02718677. Inclusion in this directory is not an endorsement.