Status:
COMPLETED
Comparison of Efficacy, Safety and Costs of Recombinant FVIII Products Between On-demand and Secondary Prophylaxis Groups in Haemophilia A Patients
Lead Sponsor:
Bayer
Conditions:
Hemophilia
Eligibility:
All Genders
18+ years
Brief Summary
The project is an observational, multi-central, prospective, non-interventional and open-label data collection study on secondary prophylaxis with recombinant FVIII products in adolescents and adults ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Severe hemophilia A (FVIII\<1%) diagnosis
- Prior treatment or ongoing treatment with on-demand or prophylaxis regimens according to Turkish guidelines and requirements
- Previously treated patients with at least \>50 exposure days
- Written informed consent signed by patient/legal representative
Exclusion
- Currently on immune tolerance treatment
- Platelet count \< 75,000/mm3
- Participation in another study
- Existence of inhibitors in the past and in the last currently available blood sample prior to study start (Bethesda titer \< 0.6 BU/ml)
- Existence of inhibitor history in family members who also are diagnosed with hemophilia A
- Having been on primary prophylaxis as defined in the introduction
- Participation in another study
Key Trial Info
Start Date :
January 4 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 23 2019
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01817868
Start Date
January 4 2013
End Date
May 23 2019
Last Update
May 27 2020
Active Locations (1)
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1
Multiple Locations, Turkey (Türkiye)