Trial Condition(s):

Hemophilia 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)

Bayer Identifier:

18251

ClinicalTrials.gov Identifier:

NCT02581969

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Completion of follow-up in the original Potter study without having being excluded from the Intention To Treat efficacy analysis of the primary endpoint;
- Written informed consent specifically issued for the 5-year extension.
Exclusion Criteria
- Switching of treatment to a Factor VIII concentrate different from Kogenate Bayer/Helixate NexGen after the end of the previous follow-up period.

Trial Summary

Enrollment Goal
43
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Italy

Status
Completed
 

Trial Design