Trial Condition(s):

Hemophilia

Comparison of efficacy, safety and costs of recombinant FVIII products between on-demand and secondary prophylaxis groups in haemophilia A patients

Bayer Identifier:

16368

ClinicalTrials.gov Identifier:

NCT01817868

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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 with severe hemophilia A (FVIII < 1%).
It will be a controlled observation of patients on secondary prophylaxis versus on-demand treatment regimen. Patients will be enrolled preferably on a 1:1 basis with regards to prophylaxis and on-demand treatment.
The patient enrollment period will be 2 years with a follow-up (observation period) of 2 years for each patient. Based on the primary effectiveness parameters (joint bleeds and overall bleeds per year) an observation period of 2 years is considered sufficient although it has to be admitted that it is rather short to assess the progression of orthopedic status. Previously treated prophylaxis patients with at least 50 exposure days and patients with continuing prophylaxis treatment will be included.

Inclusion Criteria
-  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 Criteria
-  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

Trial Summary

Enrollment Goal
73
Trial Dates
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Phase
N/A
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, Turkey

Status
Active, not recruiting
 

Trial Design