N/A
N=101
Study Evaluating Pharmacovigilance Of Refacto AF
Hemophilia A
Bottom Line
View on ClinicalTrials.gov: NCT00895037 ↗Enrolled (actual)
101
Serious AEs
33.7%
Results posted
Jul 2018
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 15; 59; 2; 7 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ReFacto AF (Moroctocog alfa) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
15; 59; 2; 7; 25; 2 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
2; 7; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Factor VIII (FVIII) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay |
1; 2; 0 | — |
| PRIMARY Mean Total Number of Bleeding Episodes in Participants |
71.2; 15.4; 68.5 | — |
| SECONDARY Mean Total Number of Bleeding Episodes Per Year in Participants |
18.6; 5.1; 13.4 | — |
| SECONDARY Number of Participants With Change From Baseline Status in Days Missed From School or Work |
4; 25; 4; 29; 3; 6 | — |
| SECONDARY Participant Assessment of Satisfaction With Treatment Handling |
13; 42; 0; 5; 28; 2 | — |
| SECONDARY Investigator Assessment of Treatment Satisfaction of Participants |
13; 44; 0; 4; 29; 2 | — |
Summary
The purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.
Eligibility Criteria
Inclusion Criteria
- Patients with hemophilia A of any severity already receiving or starting treatment with ReFacto AF.
Exclusion Criteria
- Patients with Hemophilia A treated with a product other than Refacto AF.
Data sourced from ClinicalTrials.gov (NCT00895037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.