BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-03-31

Brief Summary

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The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design.

In addition, the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment and health-economic data will be assessed.

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Detailed Description

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Conditions

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Hematologic Disease Hemophilia A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rFVIII-FS (octocog-alfa), (Kogenate FS)

On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.

Group Type EXPERIMENTAL

Kogenate (BAY14-2222)

Intervention Type DRUG

One group two treatment schedules, first on-demand then switch to prophylaxis

Interventions

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Kogenate (BAY14-2222)

One group two treatment schedules, first on-demand then switch to prophylaxis

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Severe hemophilia A (\< 1% FVIII)
* 30-45 years of age
* Previously treated subject (\> 100 Exposure days to any FVIII)
* On-demand therapy with any FVIII

Exclusion Criteria

* No history of inhibitor
* No planned elective orthopedic surgery during the study duration (13 months)
* No severe concomitant disease
* No history of anaphylactic or other severe reaction to previous FVIII treatment

Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No