Trials / Completed
CompletedNCT02581969
Extension at 10 Years of the: "Observational Study Evaluating Efficacy and Costs of Secondary Prophylaxis vs On-demand Therapy With Kogenate Bayer in Patients With Severe Haemophilia A."
Extension at 10 Years of the: "Observational Study Evaluating Efficacy and Costs of Secondary Prophylaxis vs On-demand Therapy With Kogenate Bayer in Patients With Severe Haemophilia A." POTTER-10
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 43 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 17 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
Following the performance of the POTTER observational study, whose primary objective was to collect data on the benefits of secondary prophylaxis versus on demand treatment in terms of prevention of bleeding episodes, the present study aims to extend the observation time up to 10 years, of the same population involved in the previous study. The present study has been designed to allow a focus on long term disease-related damage at joint level in subjects with severe haemophilia A, as well as on the pharmacoeconomics impact of the two different treatment regimens.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant Factor VIII (Kogenate FS, BAY14-2222) | Administered 20-30 IU/kg 3 times a week |
| DRUG | Recombinant Factor VIII (Kogenate FS, BAY14-2222) | Administered only for bleeding episodes |
Timeline
- Start date
- 2016-04-14
- Primary completion
- 2017-03-16
- Completion
- 2018-06-21
- First posted
- 2015-10-21
- Last updated
- 2020-11-18
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02581969. Inclusion in this directory is not an endorsement.