Trial Condition(s):

Hemophilia A

Prophylaxis versus On-demand Therapy Through Economic Report (POTTER)

Bayer Identifier:

11856

ClinicalTrials.gov Identifier:

NCT01159587

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The project is a controlled observational, multicenter, prospective data collection on secondary prophylaxis with Kogenate Bayer in adolescents and adults with severe haemophilia A (FVIII < 1%).

The observational period will cover at least 5 years per patient.

The long-term secondary prophylaxis group will be compared versus on-demand treatment group by the assessment of orthopedic status progression and pharmacoeconomics evaluation.

Inclusion Criteria
- age ≥ 12 years and ≤ 55 years
 - severe haemophilia A (FVIII < 1%)
 - absence of inhibitors (Bethesda titre < 0.6 BU/ml) 
 - Previous Treated Patients (prior exposure days > 200)
 - Kogenate Bayer administered 20-30 IU/kg -3 times a week, for the prophylaxis group
 - ≥ 6 joint bleeds requiring treatment with FVIII concentrates in the previous 6 months before enrollment, for on-demand group
 - written informed consent
Exclusion Criteria
- concomitant severe and chronic diseases or congenital skeletal malformation
 - unreliability of patient or likelihood of follow-up failure
 - presence of inhibitors or history of inhibitors (in the previous 2 years)
 - currently on immune tolerance treatment
 - hepatic cirrhosis or liver disease in rapid progression 
 - AIDS 
 - platelet count < 75,000/mm3
 - presence of conditions that influence negatively patient´s compliance  
 - participation in another study

Trial Summary

Enrollment Goal
58
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, Italy

Status
Active, not recruiting
 

Trial Design