Prophylaxis Versus On-demand Therapy Through Economic Report

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Factor VIII

Criteria

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