Trials / Completed
CompletedNCT02830477
Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis
A Multinational Phase IV Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 313 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to investigate weekly prophylaxis dosing regimens used in standard clinical practice. In addition the study will capture reported bleed rate, pattern of change in KOVALTRY prophylaxis dose \& dosing frequency, reason for choice of treatment regimen, FVIII product switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data (if performed), KOVALTRY consumption, as well as safety data.
Detailed description
Open label, prospective, non-interventional, single arm study in patients receiving KOVALTRY as prophylaxis therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973 | unmodified, full length recombinant FVIII |
Timeline
- Start date
- 2016-10-14
- Primary completion
- 2020-12-01
- Completion
- 2021-03-01
- First posted
- 2016-07-13
- Last updated
- 2023-11-07
Locations
25 sites across 13 countries: United States, Belgium, Canada, Colombia, France, Germany, Greece, Italy, Luxembourg, Netherlands, Slovenia, Spain, Taiwan
Source: ClinicalTrials.gov record NCT02830477. Inclusion in this directory is not an endorsement.