Prophylaxis Versus On-demand Therapy Through Economic Report

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-07-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Intervention Type DRUG

Long-term secondary prophylaxis with product administered 20-30 UI /kg three times weekly

Group 2

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Intervention Type DRUG

On-demand treatment with product given only for bleeding episodes

Interventions

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Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Long-term secondary prophylaxis with product administered 20-30 UI /kg three times weekly

Intervention Type DRUG

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

On-demand treatment with product given only for bleeding episodes

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No