Brief Title
Prophylaxis Versus On-demand Therapy Through Economic Report
Official Title
Observational Study Evaluating Efficacy and Costs of Secondary Prophylaxis vs On-demand Therapy With Kogenate Bayer in Patients With Severe Haemophilia A. POTTER
Brief 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.
Study Type
Observational
Primary Outcome
Evaluate the efficacy, safety and pharmacoeconomic of long-term secondary prophylaxis with Kogenate Bayer in comparison to on-demand treatment with Kogenate Bayer in terms of joint bleeding episodes per year
Secondary Outcome
Efficacy, safety, pharmacoeconomic impact of secondary prophylaxis versus on demand group in terms of overall bleeding episodes
Condition
Hemophilia A
Intervention
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Study Arms / Comparison Groups
Group 1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
58
Start Date
July 2004
Completion Date
December 2010
Primary Completion Date
December 2010
Eligibility 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
Gender
All
Ages
12 Years - 55 Years
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT01159587
Organization ID
11856
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
April 2011